MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-05 for TENACULUM 30-5580 UNKNOWN manufactured by Codman And Shurtlett, Inc..
[18357]
As a transvaginal hysterectomy was being completed, it was noted a small piece of tenaculum had broken off at some point during the case. The piece could not be visualized so a pelvic x-ray was obtained which was read as negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 34368 |
| MDR Report Key | 34368 |
| Date Received | 1996-07-05 |
| Date of Report | 1996-07-02 |
| Date of Event | 1996-06-27 |
| Date Facility Aware | 1996-06-27 |
| Report Date | 1996-07-02 |
| Date Reported to FDA | 1996-07-05 |
| Date Reported to Mfgr | 1996-07-04 |
| Date Added to Maude | 1996-07-25 |
| 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 | TENACULUM |
| Generic Name | TENACULUM |
| Product Code | HDC |
| Date Received | 1996-07-05 |
| Model Number | 30-5580 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 35726 |
| Manufacturer | CODMAN AND SHURTLETT, INC. |
| Manufacturer Address | 325 PARMOUNT DR. RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-07-05 |