MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCT INC. GOMCO CIRCUMCISION CLAMP; GOMCO CIRCUMCISION CLAMP NEWBORN 1.3CM

Model Number 02-01-0500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

We have become aware of an incident involving a circumcision clamp part number 02-01-0500.The clamp was used to perform a circumcision procedure and the doctor noticed that there was more bleeding than usual, and he needed to use more sutures than usual.We further know that no permanent problems were expected, and the patient has healed up normally.Sutures and bleeding are normal per the instructions for use.He sent us the clamp for investigation because he stated that the hole in the plate is not symmetrical as normal.We are currently investigating the issue.

Event Description

The doctor used one of these clamps in a procedure.The doctor noticed that there was more bleeding than usual, and he needed to use more sutures than usual.

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: GOMCO CIRCUMCISION CLAMP NEWBORN 1.3CM
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCT INC.; 1720 sublette avenue; st. louis MO 63110
• Manufacturer (Section G): ALLIED HEALTHCARE PRODUCT INC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 14255015
• MDR Text Key: 297159799
• Report Number: 1924066-2022-00001
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 00026072002308
• UDI-Public: 00026072002308
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02-01-0500
• Device Catalogue Number: 02-01-0500
• Device Lot Number: 20210506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male