MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-05 for CHROMIC GUT SUTURE N/A UNKNOWN manufactured by Davis-gech.
[11764]
During closure of an abdominal incision, suture needle snapped and tip broke off. Tip unable to be located visually. Abdominal x-ray done. Tip of needle located. Wound re-explored and tip of needle retrieved. Wound re-sutured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17465 |
| MDR Report Key | 17465 |
| Date Received | 1994-10-05 |
| Date of Report | 1994-04-13 |
| Date of Event | 1994-03-21 |
| Date Facility Aware | 1994-03-29 |
| Report Date | 1994-04-13 |
| Date Reported to Mfgr | 1994-04-13 |
| Date Added to Maude | 1994-11-08 |
| 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 |
| 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 | CHROMIC GUT SUTURE |
| Generic Name | SUTURE NEEDLE |
| Product Code | HAS |
| Date Received | 1994-10-05 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | 3-0 SUTURE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17393 |
| Manufacturer | DAVIS-GECH |
| Manufacturer Address | ONE CYANAMID PLAZA WAYNE NJ 07470 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-10-05 |