MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-06 for ETHICON SUTURE * manufactured by Ethicon.
[20156413]
In 2007, needle tip broke off when closing patient's abdomen. Tip retrieved by md. Ethicon monocryl 1 ctx. Route: cutaneous, dates of use:approx two months in 2007, diagnosis or reason: surgical suture material, event abated after use stopped or dose reduced? Yes, event reappeared after reintroduction? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003670 |
| MDR Report Key | 910346 |
| Date Received | 2007-09-06 |
| Date of Report | 2007-09-06 |
| Date Added to Maude | 2007-09-19 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON SUTURE |
| Generic Name | ETHICON SUTURE |
| Product Code | HAS |
| Date Received | 2007-09-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 887816 |
| Manufacturer | ETHICON |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-06 |