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 Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Ambulation Difficulties (2544)

Event Date 02/19/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).No additional information is available.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2014 and the mesh was implanted.It was reported that the patient had pain in groin, hips and difficulty climbing the stairs.It was reported that walking became more difficult and heavy in the lower abdomen for the patient.It was also reported that the patient had a uti, vaginal infection, back pain and difficulty swimming or trying to exercise.It was reported that it pulls in the groin to the ankles, passing behind the knees.It was also reported if the patient tries to exercise, the pain increases in the groin, knees and left hips, but worse on the right side.It was also reported that the patient had pain during intercourse with partner which had been constant since 2014.It was also reported that the patient had difficulty sleeping on the left and right side, but worse on the left and very painful if it is a urinary tract infection or vaginal infection.It was reported that the patient's condition worsened since (b)(6) 2019, but the pain was present from the start of the operation for the device in (b)(6) 2014.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12200331
• MDR Text Key: 262663418
• Report Number: 2210968-2021-06517
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• 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