MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. GOMCO 1.45; CLAMP, CIRCUMCISION

Model Number 899

Device Problem Device Slipped (1584)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

During the circumcision, the physician screwed on the clamp tightly.After about 5 minutes, the physician began to trim the foreskin.As he was trimming the foreskin, the clamp slid off.There was a considerable amount of blood.The physician applied pressure for over 20 minutes.A surgical dressing was applied to the site.Subsequently, it was determined that the infant sustained some separation of the ventral skin at the site of the circumcision.It was decided to treat the infant with neosporin ointment and let it heal on its own.

• Brand Name: GOMCO 1.45
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette avenue; st. louis MO 63110
• MDR Report Key: 4529874
• MDR Text Key: 21846179
• Report Number: 4529874
• Device Sequence Number: 1
• Product Code: HFX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2015

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
• Device Operator: Physician
• Device Model Number: 899
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DAY