MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information was requested, but unavailable: the patient demographic info: age, weight, bmi at the time of index procedure.Date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? were there any intra-operative complications? were any concomitant procedures performed? what were current symptoms following the index surgical procedure? onset date? 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? onset date/time of the pain from surgery? location and character of the pain? what medical intervention was given for the pain management? results? please provide the date and surgical findings for the mesh removal.What is the patient's current status? 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.

Event Description

It was reported that a patient underwent a gynecological procedure on an unknown date and mesh was implanted.The patient experienced chronic pain and was referred for total mesh removal.No further information is available.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10434656
• MDR Text Key: 203824067
• Report Number: 2210968-2020-06266
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• 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