MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-15 for NASOPORE STANDARD 8CM, 8/PK 5400010008 manufactured by Stryker Instruments-kalamazoo.
[145110829]
A follow up report will be filed once the quality investigation is complete. Product used by patient, not available for return.
Patient Sequence No: 1, Text Type: N, H10
[145110830]
It was reported that post operatively that the nasopore product did not fragment after the patient had irrigated the product with saline spray. It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event. It was also reported that the surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2019-01686 |
| MDR Report Key | 8611889 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-15 |
| Date of Report | 2019-06-20 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-06-20 |
| Date Added to Maude | 2019-05-15 |
| 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 | MRS. UNA BARRY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASOPORE STANDARD 8CM, 8/PK |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2019-05-15 |
| Catalog Number | 5400010008 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |