MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-04-28 for GYN DISPOSABLES TENACULUM 356T manufactured by Gyn Disposables.
[15535699]
Doctor stated: "i had tried the iud insertion kit (b)(6), and it did not work. The tenaculum would split at the end and not allow me to grasp a small cervix on a nulliparous woman. " "after discussing the issue with your office, a dvd was sent to me describing the product and its correct us (sic). I viewed the dvd and then attempted today to use it again, but had the same results. The result was that it took longer to grasp the cervix, resulted in several stabs, more pain, and i had to resort to a cervical block to continue the procedure. I have inserted lots of these iuds before and this just does just not help. In both cases, i had to resort to my autoclaved stainless steel instruments. "
Patient Sequence No: 1, Text Type: D, B5
[15850117]
Catalog #356t, lot # 313967, 314025, 314152 or 314273 (included in (b)(4), iud insertion kit, lot # 29510365). Method: product was not returned. Evaluation by analyzing design of tenaculum vs. Physician's narrative and considering that there is a "learning curve" for some physicians. Additional information: this report is being filed after the fact. At the time gym disposables received the physician's letter, a complaint was opened and investigated. Gyn disposables did not consider the event a reportable event because some pain is associated with the use of any tenaculum and the use of a cervical block (lidocaine injection) is a standard of care for some physicians when they use a tenaculum. Other physicians perform a procedure without lidocaine unless the patient experiences excessive pain. A recent audit made the observation that this complaint should be reportable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006365741-2011-00001 |
| MDR Report Key | 2094136 |
| Report Source | 05 |
| Date Received | 2011-04-28 |
| Date of Report | 2011-04-27 |
| Date of Event | 2009-07-22 |
| Date Mfgr Received | 2009-07-27 |
| Device Manufacturer Date | 2008-10-30 |
| Date Added to Maude | 2012-06-11 |
| 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 Contact | BILLY HANNAFORD |
| Manufacturer Street | 3170 STAGE POST RD STE 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 DISPOSABLES TENACULUM 356T |
| Generic Name | TENACULUM |
| Product Code | HDC |
| Date Received | 2011-04-28 |
| Catalog Number | 356T |
| Lot Number | 313967 |
| Device Expiration Date | 2011-05-31 |
| 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 | 2011-04-28 |