MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-23 for AUTO SUTURE PDB 52 OVAL PREPERITONEAL DISTENTION BALLOON AND * manufactured by United States Surgical.
[272419]
The auto suture pdb 52 oval preperitoneal distention balloon and inflation bulb device was being used during a surgical procedure. The balloon separated from the auto suture 10mm pdb, upon removal from the abdomen. Therefore, the balloon remained inside the pt's abdomen, necessitating removal of balloon via the scope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 389907 |
| MDR Report Key | 389907 |
| Date Received | 2002-04-23 |
| Date of Event | 2002-02-22 |
| Date Facility Aware | 2002-02-22 |
| Date Added to Maude | 2002-04-26 |
| 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 | 0 |
| 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 | AUTO SUTURE PDB 52 OVAL PREPERITONEAL DISTENTION BALLOON AND |
| Generic Name | * |
| Product Code | FGY |
| Date Received | 2002-04-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 108114 |
| ID Number | * |
| Device Expiration Date | 2006-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 378954 |
| Manufacturer | UNITED STATES SURGICAL |
| Manufacturer Address | * NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-04-23 |