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

Catalog Number TVTUNK

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

Patient Problems Dehydration (1807); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Skin Irritation (2076); Swelling (2091); Tachycardia (2095); Urinary Retention (2119); Urinary Tract Infection (2120); Weakness (2145); Urinary Frequency (2275); Hypoesthesia (2352); Ambulation Difficulties (2544); Abdominal Distention (2601)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on (b)(6) 2006 and the mesh was implanted.After the surgery, urination has never been normal and the patient experienced interference, voiding phase retention, nocturia, frequent micturition since 2006.The patient was constantly dehydrated and had internal heat, intolerant heat, elevated blood values and blood pressure.The patient had to rehydrate every day with resorb.Neurological symptoms that vary, but immediately after the operation, the patient could no longer run and walk became slow.Sometimes legs shake.Within a year, pain in the groin, around the bladder, buttock and legs has been increased and the patient was also bedridden for 3-4 months the first time due to intense pain.It was also reported that pain in pelvis, back, hips increased and the patient experienced piriformis syndrome, foot drop, numbness around the genitals, anal incontinence, loose stool with mucus, soreness in the anal area, distended and painful stomach.In 2007 the cystoscopy was performed, and the physician opined that problems were not associated with the initial surgery.Libido disappeared shortly after and has not returned.It was also reported that symptoms started immediately after the surgery, but also during the intervention, something felt wrong.It was a local surgery.Since (b)(6) 2017, the patient has not been able to walk and was mostly bedridden.The patient experienced abnormal bowel movements, recurring swelling, tightness from the groin the whole way up to the ribs, constant pain from inflammation in the body, severe recurrent allergic skin symptoms, fungal infection, shortness of breath that arose after the operation and which has worsened over the years.Episodes similar to urinary tract infections recur all the time, which are not indicated on usual standard tests at a healthcare center.The patient experienced foreign body reactions and a mild reaction to sanitary pads, surgical tape and plasters which contain polypropylene.The patient now sometimes is getting breaking teeth and intense tooth pain in the whole cheek and jaw after getting a filling at the dentist in 2018, which contains polypropylene.The patient is getting help with finding physicians who can do pelvic examinations and remove the mesh.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-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8372755
• MDR Text Key: 137248844
• Report Number: 2210968-2019-79096
• 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: consumer,foreign,other
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TVTUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• 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
• Patient Weight: 72