MAUDE Adverse Event Report: TELEFLEX MEDICAL UNKNOWN MOGEN CLAMP

Catalog Number SURGICAL UNKNOWN

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/21/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the mogen clamp was used by a nurse mid-wife to perform a circumcision procedure, in which the glans of the patient's penis was severed.The patient's condition is unknown.

Manufacturer Narrative

(b)(4).Device history record dhr) was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to circumcision clamps.No sample or photos received were received, therefore; based on the function and specifications of the mogen clamp, it is extremely unlikely that the device was responsible for the harm caused.The opening of this device is a slit less than 1/8" wide.There are no sharp edges and the device does not cut tissue.

Event Description

Alleged event: the mogen clamp was used by a nurse mid-wife to perform a circumcision procedure, in which the glans of the patient's penis was severed.The patient's condition is unknown.

• Brand Name: UNKNOWN MOGEN CLAMP
• Type of Device: CLAMP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5011102
• MDR Text Key: 23333024
• Report Number: 1044475-2015-00287
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: GG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1