MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-15 for PHOTOFIX PATCH PFP0.8X8 manufactured by Cryolife, Inc..
[138971370]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[138971411]
According to the initial report, (b)(6) was enrolled into the (b)(6) study on (b)(6) 2019. The patient was implanted with a photofix patch as part of his left femoral endarterectomy procedure. The site submitted an adverse event electronic case report form (ecrf) reporting pain in the left groin. The patient went to his pmd where he was prescribed a 7 day course of ciprofloxacin 500mg. There were no additional details provided on symptoms, evidence of infection, or relation to the patient? S surgery or photofix. The partially completed adverse event ecrf is attached. The site was asked to provide answers to the event? S relation to the surgery and to photofix. The site is expected to also finish completion of the ecrf. The site response and completed ecrf is currently pending. Additional information indicates date of surgery was (b)(6) 2019. The pain experienced by patient began on (b)(6) 2019. The event was reported on (b)(6) 2019 and resolved on (b)(6) 2019. Per the office note of the operating surgeon from (b)(6) 2019, " status post left leg profunda endarterectomy; has some pain in the left groin; was concerned about redness and went to his pmd who started him on a 7 day course of abx; no fevers, no drainage; left femoral incision is clean. No erythema; ultrasound with patent vessel. Unable to completely assess profunda secondary to incisional discomfort; follow up one month"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00009 |
| MDR Report Key | 8426010 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-15 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-02-12 |
| Date Facility Aware | 2019-03-01 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOTOFIX PATCH |
| Generic Name | INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED |
| Product Code | PSQ |
| Date Received | 2019-03-15 |
| Model Number | PFP0.8X8 |
| Catalog Number | PFP0.8X8 |
| Lot Number | 31071118 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-15 |