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 |