MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Neurological Deficit/Dysfunction (1982); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure.The initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? what were current symptoms following the index surgical procedure? onset date? how was the mesh found lying across urethral lumen diagnosed? describe medical/surgical intervention including dates if reoperation: please provide the date.What were the findings on reoperation? are there any pictures available for evaluation? other relevant patient history/concomitant medications.Product code and lot number.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient current status?.

Event Description

It was reported that the patient underwent a gynecological procedure in 2008 and mesh was implanted.The mesh was recently found to be lying across the urethral lumen causing irritative bladder symptoms.The patient has been referred to mesh removal center.Additional information has been requested.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7855254
• MDR Text Key: 119531718
• Report Number: 2210968-2018-75696
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention