MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-28 for AUTOSUTURE OMST10SB * manufactured by United States Surgical Corp..
[151540]
The balloon did not inflate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018786 |
| MDR Report Key | 276054 |
| Date Received | 2000-04-28 |
| Date of Report | 2000-04-27 |
| Date of Event | 2000-04-27 |
| Date Added to Maude | 2000-05-04 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOSUTURE |
| Generic Name | INFLATION BULB |
| Product Code | FHO |
| Date Received | 2000-04-28 |
| Model Number | OMST10SB |
| Catalog Number | * |
| Lot Number | 203219 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 267192 |
| Manufacturer | UNITED STATES SURGICAL CORP. |
| Manufacturer Address | 150 GLOVER AVE. NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-04-28 |