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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Neuropathy (1983); Pain (1994); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Hypoesthesia (2352); Abdominal Distention (2601); Not Applicable (3189)

Event Date 11/13/2009

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.If in your possession, may we have a copy of your operative report? do we have your permission to contact your surgeon?.

Event Description

It was reported by the patient that they underwent a sling procedure on an unknown date.The patient experienced severe infection immediately after initial operation and was readmitted to hospital for three weeks.The patient reports ongoing difficulty urinating, extreme back, abdominal and groin pain, severe abdominal bloating with associated pain, extreme weakness of left side of body, undiagnosed neurological issues such as falling over, loss of balance, severe numbness down both legs, especially after sitting on toilet, and severe pins and needles down both legs and arms, burning sensation in legs and feet at night, extreme tiredness, recurrent utis, ripping of abdominal wall lining, recent bladder wall prolapse (cystocele).Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 2/15/2018.

• Brand Name: TENSION FREE VAGINAL TAPE - SECUR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 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 08876-0151 ; 9082182792
• MDR Report Key: 7222828
• MDR Text Key: 98404321
• Report Number: 2210968-2018-70487
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention