MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-22 for GYN DISPOSABLE TENACULUM 356T manufactured by Gyn-disposables.
[1133814]
Nurse practitioner says that one of the tenaculum tips broke while she was removing the tenaculum from the cervix (after an iud insertion procedure). She tried to find the broken piece and was unsuccessful. There was no further intervention required. The tip protector was in place when package was opened. The nurse practitioner disposed of the tenaculum so it cannot be returned for eval. Nurse practitioner did not notify mfr at the time of the occurrence as she did not feel that this occurrence was a big concern. The incident was discovered on (b)(6) 2009 when mfr made a sales follow-up telephone call. On 06/22/2009, mfr made a follow-up telephone call to the nurse practitioner who said that there were no complications with the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006365741-2009-00001 |
| MDR Report Key | 1474821 |
| Report Source | 07 |
| Date Received | 2009-06-22 |
| Date of Report | 2009-06-22 |
| Date of Event | 2009-05-11 |
| Date Mfgr Received | 2009-05-28 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2010-02-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 3150 STATE POST RD SUITE 103 |
| Manufacturer City | MEMPHIS TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013772200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYN DISPOSABLE TENACULUM 356T |
| Generic Name | TENACULUM |
| Product Code | HDC |
| Date Received | 2009-06-22 |
| Catalog Number | 356T |
| Lot Number | 935K 60134034 |
| Device Expiration Date | 2011-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYN-DISPOSABLES |
| Manufacturer Address | MEMPHIS TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-22 |