MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP; CLAMP,CIRCUMCISION,GOMCO,13MM,1.3CM

Catalog Number MDS9382113

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Fitting Problem (2183)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported that during a circumcision the clamp slipped, was loose and didn't fit well in the socket.The infant was bleeding excessively and required further (unreported) treatment to help stop the bleeding.No additional information is available.

Manufacturer Narrative

It was reported that during a circumcision the clamp slipped, was loose and didn't fit well in the socket.The infant was bleeding excessively and required further (unreported) treatment to help stop the bleeding and was being monitored.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample has not been returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: CLAMP,CIRCUMCISION,GOMCO,13MM,1.3CM
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12823803
• MDR Text Key: 280933252
• Report Number: 1417592-2021-00206
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS9382113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• 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): Required Intervention
• Patient Sex: Male