MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-21 for GYN DISPOSABLES TENACULUM 356T (COMPONENT OF GYN DISPOSABLES 935K IUD INSERTION manufactured by Gyn Disposables.
[2906632]
Nurse practitioner says that both of the tenaculum tips and the locking rachet broke during an iud procedure. She believed the size of the broken tips were approximately 5mm for the left tip and 2 to 3mm for the right tip. One tip remained lodged in pt; other tip was retrieved. Nurse practitioner said that a laceration was in back of cervix from 4 o'clock to 8 o'clock position. Pt had slight bleeding. Pt left, rescheduled appointment, checked a week later, and everything was fine. Nurse practitioner said date of occurrence was (b)(6) 2012. Gyn disposables was not informed of occurrence until (b)(6) 2012, during a sales call. Product not available for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027079 |
| MDR Report Key | 2766609 |
| Date Received | 2012-09-21 |
| Date of Report | 2012-09-12 |
| Date of Event | 2012-03-28 |
| Date Added to Maude | 2012-10-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYN DISPOSABLES TENACULUM 356T (COMPONENT OF GYN DISPOSABLES 935K IUD INSERTION |
| Generic Name | TENACULUM |
| Product Code | OJV |
| Date Received | 2012-09-21 |
| Model Number | NA |
| Catalog Number | 356T |
| Lot Number | 935K: 61172179 |
| Device Expiration Date | 2014-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-09-21 |