MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-24 for 720-350 manufactured by Grace Medical.
[34312194]
Patient Sequence No: 1, Text Type: N, H10
[34312195]
Surgery required device implant as part of the left ear reconstruction. Device implant was removed from pyxis and verified that it was the correct implant. Implant was opened from package and passed off onto sterile field. Scrub tech opened package for implant and upon inspection was found to be in pieces and not usable. The device implant was not used. Another implant was obtained from pyxis and implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5326418 |
| MDR Report Key | 5326418 |
| Date Received | 2015-12-24 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-12-12 |
| Report Date | 2015-12-16 |
| Date Reported to FDA | 2015-12-16 |
| Date Reported to Mfgr | 2015-12-16 |
| Date Added to Maude | 2015-12-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANT, OSSICULAR PROSTHESIS |
| Product Code | ETA |
| Date Received | 2015-12-24 |
| Model Number | 720-350 |
| Lot Number | 30080 |
| Device Expiration Date | 2015-12-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE MEDICAL |
| Manufacturer Address | 8500 WOLF LAKE DR., STE. 110 MEMPHIS TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-24 |