MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-20 for NASOPORE STANDARD 8CM, 8/PK 5400010008 manufactured by Stryker Instruments-kalamazoo.
[111652969]
The device is available for return. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[111652970]
It was reported during a surgical procedure, that there was a potential sterility breach on the packaging. It was also reported that there was no delay as a result of this event. It was further reported that there were no adverse consequences and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[116788279]
The product and packaging was not returned for evaluation. The reported event, for packaging issue, was not confirmed as the product and packaging was not returned for evaluation. Without the product and packaging, the root cause cannot be determined. Device not available for return, no further information available.
Patient Sequence No: 1, Text Type: N, H10
[116788280]
It was reported during a surgical procedure, that there was a potential sterility breach on the packaging. It was also reported that there was no delay as a result of this event. It was further reported that there were no adverse consequences and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-01082 |
| MDR Report Key | 7619035 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-20 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-06-20 |
| 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 | 2018-06-20 |
| Catalog Number | 5400010008 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-06-20 |