MAUDE Adverse Event Report: M.M DENTAL CORP. GOMCO CIRCUMCISION CLAMP

Model Number 1.3CM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

A report has been received indicating that during the usage of the device, the bell was pulled through the base hole creating cuts on the infants.

Manufacturer Narrative

Device 2: brand name: gomco circumcision clamp, lot # 120/100613/gc1.3cm.

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): M.M DENTAL CORP.; jinnah street mujahid pura; sialkot ; PK
• Manufacturer (Section G): SURGICAL DESIGN, INC.; 7351-d lockport pl.; lorton VA 22079
• Manufacturer Contact: 7351-d lockport pl.; lorton, VA 22079
• MDR Report Key: 4232157
• MDR Text Key: 5002855
• Report Number: 1125236-2014-00002
• 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: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2014

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: Health Professional
• Device Model Number: 1.3CM
• Device Catalogue Number: 293-08
• Device Lot Number: 1200/650/GC.1.S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2014
• Distributor Facility Aware Date: 10/10/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other