MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-USE MDS9900025K CLAMP, MOGEN, CIRCUM

Catalog Number MDS9900025

Device Problem Difficult to Open or Close (2921)

Patient Problem Genital Bleeding (4507)

Event Date 11/09/2023

Event Type  Injury  

Event Description

The lever is much more difficult to pull down causing bleeding.

Manufacturer Narrative

It was reported by the customer contact that "circumcisions performed by these mogans have resulted in increased bleeding at circ site, some of which required additional interventions".No additional information was provided.A sample has been requested to be returned for evaluation.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: DBD-USE MDS9900025K CLAMP, MOGEN, CIRCUM
• 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: 18283026
• MDR Text Key: 329944682
• Report Number: 1417592-2023-00491
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MDS9900025
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other