MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-12 for GOMCO CIRCUMCISION CLAMP UNKNOWN manufactured by Allied Healthcare Products, Inc..
[97873509]
1. We originally talked to (b)(6) who was listed on the report. She referred us to (b)(6), who originally said they would return the clamp for evaluation. We then tried to contact the hospital many times with no response. We finally got a response , which, said they will not be returning the clamp because it was involved in an incident. 2. We requested pictures which they also said they could not provide. 3. Therefore, we cannot determine the following: a. If the clamp was manufactured by allied hpi b. The age and or how often the clamp was used. C. Condition of the clamp. 4. The part number listed on the report is not ours. 5. Their report said the clamp was disposable. Our clamp is re-usable. 6. This incident was not directly reported to us. We learned of this incident from the fda. 7. We do not know if this is a genuine gomco clamp or a copy made by another manufacturer. 8. It does not appear that they followed the instructions, which are sent with each allied clamp. Which state: warning: a. This clamp must never be used if component parts are damaged, missing, clearly worn, or the assembled device does not perform as described. B. Prior to initiating the surgical procedure, you must insure that expected clamping function has been properly achieved. C. Important: some bleeding may occur and or some sutures may be required depending on the prescribed surgical technique.
Patient Sequence No: 1, Text Type: N, H10
[97873510]
It ws reported that a circumcision procedure performed by a physician, a 1. 3 gomco was used. When it was time to tighten the clamp, the physician was unable to completely tighten the nut on the threaded post. When physician turned the nut, 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 stop 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 | 1924066-2018-00001 |
| MDR Report Key | 7187317 |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-11-24 |
| Date Mfgr Received | 2017-12-12 |
| Date Added to Maude | 2018-01-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JON STILLMAN |
| Manufacturer Street | 1720 SUBLETTE AVE. |
| Manufacturer City | ST. LOUIS MO 63110 |
| Manufacturer Country | US |
| Manufacturer Postal | 63110 |
| Manufacturer Phone | 3142681616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GOMCO CIRCUMCISION CLAMP |
| Generic Name | CIRCUMCISION CLAMP |
| Product Code | HFX |
| Date Received | 2018-01-12 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE. ST. LOUIS MO 63110 US 63110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-12 |