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

Device Problem Malposition of Device (2616)

Patient Problems Erosion (1750); Not Applicable (3189)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the 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 initial surgical procedure the diagnosis and indication for the initial surgical procedure? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? how long after initial procedure was it found that the mesh exposed at suburethral part of anterior vaginal wall? were there any intra-operative complications? other relevant patient history/concomitant medications.Product code and lot #.Describe any medical/surgical intervention for exposure including dates and surgical findings.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status?.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on unknown date and the mesh was implanted.It was also reported that during removal of vaginal mesh for prolapse, a mesh exposure was discovered at suburethral part of anterior vaginal wall.The patient was asymptomatic.The vaginal epithelium was sutured over the exposed mesh.Additional information has been requested.

• Brand Name: TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
• 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-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7730020
• MDR Text Key: 115347605
• Report Number: 2210968-2018-74706
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2018

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: 07/13/2018
• Initial Date FDA Received: 07/29/2018
• 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