MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CLAMP, MOGEN, CIRCUMCISION

Catalog Number MDS9900025K

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that, the clamp "sliced the foreskin".It was reported that due to this, stitches were required.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Clamp sliced the foreskin.

Manufacturer Narrative

Including investigation conclusion.

• Type of Device: CLAMP, MOGEN, CIRCUMCISION
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19152665
• MDR Text Key: 340712508
• Report Number: 1417592-2024-00531
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MDS9900025K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other