MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-29 for AUTOSUTURE PDB S2 * manufactured by United States Surgical.
[17765229]
Autosuture shaft snapped off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036759 |
| MDR Report Key | 746479 |
| Date Received | 2005-09-29 |
| Date of Report | 2005-09-16 |
| Date of Event | 2005-09-08 |
| Date Added to Maude | 2006-08-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOSUTURE |
| Generic Name | OVAL PREP DISTENTION BALLOON & INFLATION BUL |
| Product Code | FHP |
| Date Received | 2005-09-29 |
| Model Number | PDB S2 |
| Catalog Number | * |
| Lot Number | P4H607 |
| ID Number | OMS-PDBS2 |
| Device Expiration Date | 2007-08-01 |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734276 |
| Manufacturer | UNITED STATES SURGICAL |
| Manufacturer Address | * NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-29 |