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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Urinary Frequency (2275); Not Applicable (3189)

Event Date 03/01/2015

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, weight, bmi at the time of index procedure name of initial surgery? any concurrent procedure? the diagnosis, indication and the initial approach for the initial surgical procedure? were there any intra-operative complications? other relevant patient history/concomitant medications onset time of the severe overactive bladder and bladder pain from the initial procedure? please describe medical/surgical intervention required to treat the severe overactive bladder and bladder pain and surgical findings.What the reason for surgery in october 2015 and please provide surgical findings? product code and lot #.Was the mesh removed? 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 a gynecological procedure in (b)(6) 2015 and mesh was implanted.Following the procedure, the patient experienced high residuals post op requiring cisc (clean intermittent self catheterization) for 2 weeks.The patient developed severe overactive bladder and bladder pain.In (b)(6) 2015, the patient had vaginal portion of tape removed.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: 7770680
• MDR Text Key: 116701303
• Report Number: 2210968-2018-75059
• 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,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2018

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: 07/27/2018
• Initial Date FDA Received: 08/09/2018
• 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