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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Not Applicable (3189)

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.

Event Description

It was reported by the patient that they were admitted for hysterectomy and repair in (b)(6) 2008 and mesh was implanted.The patient was informed after surgery on return to the ward that a procedure was carried out for a prolapse repair instead.The patient stated she was not fully informed of the decision, nor were the risks associated with this implant told to her.The patient has experienced excruciating pain and anxiety and discomfort since the insertion of the device and the consequences have been life changing.The patient cannot walk far or stand for long.The patient has lower back pain, her stomach swells, she has constant fizzing and tingling of lower abdomen and upper legs, constant thrush infections and hemorrhoids, shooting pain in the vagina, pelvic, and rectum.The patient has severe pressure on bowel.The patient states the prolapse was still evident.The patient experienced further problems and was re-admitted to the hospital in (b)(6) 2009 for sterilization as the risk of becoming pregnant again would have been very serious.After several consultations with various surgeons, the patient was readmitted in (b)(6) 2010 for a hysterectomy.This was a major operation and difficult as they had to bypass the mesh.The patient states her general health has deteriorated from the impact of the operation and still does today.She has attended several consultants and specialists since 2010 and continue to do so regarding chronic pain and discomfort, and patient reports that all symptoms are mesh related.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 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: 7151551
• MDR Text Key: 95948081
• Report Number: 2210968-2017-72020
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2017

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: 12/01/2017
• Initial Date FDA Received: 12/28/2017
• 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