FDA Adverse Event Malfunction Summary report: N

UNIVERSAL CIRCUMCISION KIT

MDR report key: 24617453 · Received March 17, 2026

Report

Report Number: 1030451-2026-00007
Event Type: Malfunction
Date Received: March 17, 2026
Date of Event: February 23, 2026
Report Date: April 24, 2026
Manufacturer: MEDICAL ACTION INDUSTRIES
Product Code: OHG
UDI-DI: 20809160410407
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE PRODUCT INVOLVED IN THE EVENT IS SAID TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED YET. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE CONVENIENCE KIT CONTAINING THE COMPLAINT COMPONENT: (B)(4), LOT: 25381161PP PURCHASED FROM SPECIFICATION DEVELOPER, GLOBAL INSTRUMENTS INC. (FDA REGISTRATION 1057200). THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem · 0

THE CURVED HEMOSTAT FAILED TO HOLD DURING THE PROCEDURE, AS THE INSTRUMENT TIPS WOULD NOT REMAIN SECURED OR LOCKED IN PLACE. REPORTER INDICATED THERE WAS A DELAY OF A FEW MINUTES. RESIDENTS IN-TRAINING STATED THEY FEEL INTIMIDATED WHEN THE HEMOSTATS DO NOT HOLD UP DURING CIRCUMCISION PROCEDURE AND CAN CAUSE COSMETIC ISSUES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
35638	UNIVERSAL CIRCUMCISION KIT	UNIVERSAL CIRCUMCISION KIT	OHG	MEDICAL ACTION INDUSTRIES	79069B	337986	20809160410407

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown