MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-09-19 for AUTO SUTURE EXTRA VIEW OMB-XB1 * manufactured by Auto Suture, Div Of United States Surgical Corp.
[210876]
Balloon seal failed (fell apart) while in pt during laparoscopic hernia repair. All pieces retrieved. No injury/harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 354346 |
| MDR Report Key | 354346 |
| Date Received | 2001-09-19 |
| Date of Report | 2001-09-17 |
| Date of Event | 2001-08-31 |
| Date Facility Aware | 2001-09-05 |
| Report Date | 2001-09-17 |
| Date Added to Maude | 2001-10-05 |
| 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 EXTRA VIEW |
| Generic Name | PREPERITONEAL BALLOON |
| Product Code | FGY |
| Date Received | 2001-09-19 |
| Model Number | OMB-XB1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 343566 |
| Manufacturer | AUTO SUTURE, DIV OF UNITED STATES SURGICAL CORP |
| Manufacturer Address | 150 GLOVER AVE NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-09-19 |