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

Catalog Number MDS9900025K

Device Problem Sharp Edges (4013)

Patient Problem Genital Bleeding (4507)

Event Date 02/01/2024

Event Type  Injury  

Event Description

Bleeding requiring interventions.

Manufacturer Narrative

It was reported by the customer that on (b)(6) 2024, the clamp "sliced the top left edge of the foreskin" due to the edge being too sharp.It was reported that pressure and surgicell were applied to the area.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.

• 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: 18826424
• MDR Text Key: 336780219
• Report Number: 1417592-2024-00153
• 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
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MDS9900025K
• Device Lot Number: 128573B23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Date Manufacturer Received: 02/06/2024
• 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