MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for GOMCO 02-00-0500 manufactured by Allied Healthcare Products, Inc..
[116599852]
Clamp involved was not returned for evaluation. Pictures of clamp involved do not show the size or a g stamped on the bell/stud. Hospital confirmed that there was no marking on the bell/stud. The other three parts of the clamp had proper gomco markings on them. This indicates the bell/stud was probably from a different manufacturer. Parts from clamps of different manufacturers may have been mixed during the cleaning process. We have no control over dimensions of copy cat parts made by other manufacturers. The clamp instruction manual states the following: warnings: this clamp must never be used if component parts are damaged, missing, clearly worn, or the assembled device does not perform as described. Prior to indicating the surgical procedure, you must insure that expected clamping functionals been properly achieved. Use only components parts manufactured by "gomco" when assembling this device. 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
[116599853]
It was reported that a male infant undergoing circumcision with a gomco 1. 1 cm clap. According to physician, the device did not appear to crimp down enough to seal the foreskin, causing more bleeding than normal. Added pressure to site and monitored to ensure hemostasis. Infant did not have a prolonged stay and was discharged without complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1924066-2018-00003 |
| MDR Report Key | 7753842 |
| Date Received | 2018-08-06 |
| Date Mfgr Received | 2018-06-29 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2018-08-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JON STILLMAN |
| Manufacturer Street | 1720 SUBLETTE AVE. |
| Manufacturer City | ST. LOUIS MO 63110 |
| Manufacturer Country | US |
| Manufacturer Postal | 63110 |
| Manufacturer Phone | 3147712400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GOMCO |
| Generic Name | CIRCUMCISION CLAMP |
| Product Code | HFX |
| Date Received | 2018-08-06 |
| Catalog Number | 02-00-0500 |
| Lot Number | 8-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2018-08-06 |