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

Catalog Number MDS9900025K

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Date 12/01/2023

Event Type  Injury  

Event Description

According to the customer, during circumcision the mogen clamp is causing a "tear" on the "foreskin".

Manufacturer Narrative

According to the customer, during circumcision the mogen clamp is causing a "tear" on the "foreskin".The customer reported the tearing causes "persistent oozing of blood" requiring "pressure hemostasis".The customer reported it was "not a clean cut" therefore it "required care after the procedure".The customer reported that the reported issue led to an "uncomfortable infant".Sample requested for return 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: CLAMP, MOGEN, CIRCUMCISION
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18373912
• MDR Text Key: 331116133
• Report Number: 1417592-2023-00514
• 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: 12/21/2023

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 Operator: Health Professional
• Device Catalogue Number: MDS9900025K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/21/2023
• 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