MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-01 for PREFIX PPF M0068506000 * manufactured by Boston Scientific.
[20619735]
Obturator was sticking and would not advance mesh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006532 |
| MDR Report Key | 1037571 |
| Date Received | 2008-05-01 |
| Date of Report | 2008-05-01 |
| Date of Event | 2008-04-07 |
| Date Added to Maude | 2008-05-13 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREFIX PPF |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 2008-05-01 |
| Model Number | M0068506000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1008288 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | * QUINCY MA 02171 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-01 |