MAUDE Adverse Event Report: TRI-STATE DE MEXICO MEDLINE INDUSTRIES, INC.; GOMCO CLAMP 1.45CM

Model Number DYND04197

Device Problem Positioning Failure (1158)

Patient Problem Genital Bleeding (4507)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

Report originally submitted in error under incorrect manufacturing number (1824619-2020-00010).It was reported that the circumcision device would not screw down far enough during a circumcision to prevent the penis from bleeding.The doctor stated that he screwed the device down as tight as he could, and when he removed the device the penis bled.Pressure had to be applied and the doctor put a surgical absorbable hemostat on the area to control the bleeding.There was no additional medical intervention required and the baby was reportedly doing fine.Un-used samples were returned to the manufacturer for evaluation it was determined that the facility was disassembling and sterilizing the device in an autoclave prior to use against manufacturer instructions.No additional information is available.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.

Event Description

It was reported that the circumcision device would not screw down far enough during a circumcision to prevent the penis from bleeding.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GOMCO CLAMP 1.45CM
• Manufacturer (Section D): TRI-STATE DE MEXICO; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10705480
• MDR Text Key: 212265312
• Report Number: 3004519921-2020-00001
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 10889942395415
• UDI-Public: 10889942395415
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYND04197
• Device Catalogue Number: DYND04197
• Device Lot Number: 2020050490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 10/13/2020
• 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): Required Intervention
• Patient Age: 10 DA