MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for FLYTE SURGICOOL ZIPPERED TOGA 0408-831-000 manufactured by Stryker Instruments.
[143406816]
Upon opening stryker, flyte surgical zippered toga, x-large, a long dark hair was discovered in the sterile package. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086206 |
| MDR Report Key | 8555705 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-23 |
| Date Added to Maude | 2019-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | FLYTE SURGICOOL ZIPPERED TOGA |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYA |
| Date Received | 2019-04-25 |
| Model Number | 0408-831-000 |
| Catalog Number | 0408-831-000 |
| Lot Number | 19010219 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |