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

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

Patient Problems Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Urinary Retention (2119); Ambulation Difficulties (2544)

Event Date 05/04/2015

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.

Event Description

It was reported that the patient underwent a hysterectomy, with anterior and posterior repair and colonoscopy on an unknown date to treat prolapse and very mild urinary incontinence and mesh was implanted.The patient reported she has experienced chronic pain, depression, isolation, excessive urinary incontinence, developed fecal incontinence, severe lower back pain, hip, thigh, groin and vaginal spasms, urinary retention, inability to sit, walk or stand more than 5 minutes, disability, inability to work or drive, anxiety, chronic recurrent infections, inflammation, chronic pain and is immune compromised.The patient additionally reported that she underwent therapy including hydrotherapy, acupuncture, psychologist and psychiatrist.She underwent pain management with guided injections and 5 days of unsuccessful ketamine infusion.No additional information is available.

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
• 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: 10039123
• MDR Text Key: 190479717
• Report Number: 2210968-2020-03783
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132054
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• 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: 04/23/2020
• 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