MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-24 for GOMCO TYPE CIRCUMCISION DISPOSABLE CHROME PLATED NEW BO UNK 28-855 manufactured by Fine Surgical Instruments, Inc. / Allied Healthcare Products, Inc..
[92960824]
Circumcision procedure performed by physician. A 1. 3 disposable gomco was used. When it was time to tighten the clamp, physician was unable to completely tighten using the nut on the threaded post. When physician turned the night, it would spin around, but would not move down the threads to tighten the clamp. Due to the inability to completely tighten the clamp during the procedure, additional pressure and silver nitrate were applied by the physician to stoop the "oozing". After the procedure was completed, the gomco clamp was removed and inspected. A small defect was noted on the threads about midway down the post.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073553 |
| MDR Report Key | 7057419 |
| Date Received | 2017-11-24 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-10-03 |
| Date Added to Maude | 2017-11-24 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GOMCO TYPE CIRCUMCISION DISPOSABLE CHROME PLATED NEW BO |
| Generic Name | GOMCO CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2017-11-24 |
| Model Number | UNK |
| Catalog Number | 28-855 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FINE SURGICAL INSTRUMENTS, INC. / ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | HEMPSTEAD NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-24 |