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

Model Number	02-01-0500
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1924066-2022-00001
• Device Sequence Number: 17533574
• Product Code: HFX
• UDI-Device Identifier: 00026072002308
• UDI-Public: 00026072002308
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male