MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for FORMULA 0375940200 0375-940-200 manufactured by Stryker Endoscopy.
[185223692]
Discovered what appears to be a hair within the seal of the packaging - part of contaminant inside packaging with device and part of contaminant outside the packaging. Package not opened; no patient exposure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888151 |
| MDR Report Key | 9888151 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-25 |
| Report Date | 2020-03-26 |
| Date Reported to FDA | 2020-03-26 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Brand Name | FORMULA |
| Generic Name | BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL |
| Product Code | GFA |
| Date Received | 2020-03-27 |
| Model Number | 0375940200 |
| Catalog Number | 0375-940-200 |
| Lot Number | 18277CE2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL CT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |