MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - LAREDO GOMCO CLAMP 1.3CM; CLAMP, CIRCUMCISION

Model Number 1213 EITHER (C OR G) UNABLE TO D

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem Discomfort (2330)

Event Date 04/26/2023

Event Type  Injury  

Event Description

Circumcision complicated by defective gomco bell.Upon completion of foreskin removal, after removal of gomco bell from glans, noted a metallic foreign body on left aspect of distal shaft.Inspection of gomco bell notable for a chip, with missing metallic finish on bell corresponding to foreign body noted on patient.Foreign body removed with forceps, and there was no notable tissue injury in associated area or bleeding from site.I do not think this will necessarily result in lasting harm to patient, but he did seem on the upper end of typical discomfort level during procedure and it could have been attributed to this.Risk of not removing would have included: it would have embedded into his skin at the very least, and likely have cause pain until noted and removed.It also could have resulted in a hypersensitivity reaction or other complication such as infection, toxic shock, etc.

• Brand Name: GOMCO CLAMP 1.3CM
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - LAREDO
• MDR Report Key: 16895123
• MDR Text Key: 314947911
• Report Number: MW5117389
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1213 EITHER (C OR G) UNABLE TO D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Ethnicity: Hispanic