MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-11 for AUTOSUTURE PDB S2 * (01)000613830132485 manufactured by United States Surgical Corporation.
[313534]
The surgical procedure being performed was laparoscopic bilateral inguinal herniorrhaphy. The oval-preperitoneal distention balloon which is the initial one inserted and bulb inflated had the bag tear off as surgeon was trying to remove it. The bag was retrieved at the end of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 554898 |
| MDR Report Key | 554898 |
| Date Received | 2004-11-11 |
| Date of Report | 2004-11-11 |
| Date of Event | 2004-09-21 |
| Report Date | 2004-11-11 |
| Date Reported to FDA | 2004-11-11 |
| Date Added to Maude | 2004-11-17 |
| Event Key | 0 |
| Report Source Code | User Facility 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 PDB S2 |
| Generic Name | OVAL-PREPERITONEAL DISTENTION BALLOON AND INFLATION BULB |
| Product Code | FGY |
| Date Received | 2004-11-11 |
| Model Number | * |
| Catalog Number | (01)000613830132485 |
| Lot Number | P4G1158 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 544530 |
| Manufacturer | UNITED STATES SURGICAL CORPORATION |
| Manufacturer Address | DIVISION OF TYCO HEALTHCARE GR 195 MCDERMOTT ROAD NORTH HAVEN CT 06473 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-11 |