MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810081

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

Patient Problems Edema (1820); Itching Sensation (1943); Pain (1994); Rash (2033); Skin Irritation (2076); Ambulation Difficulties (2544)

Event Date 10/24/2018

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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date of index surgical procedure does the patient have known allergic history to medical device, food or medications? was there any allergy testing performed? if yes, results? other relevant patient history/concomitant medications if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient current status?.

Event Description

It was reported that the patient underwent procedure for stress urinary incontinence and colporrhaphy on (b)(6) 2018 and mesh was implanted.A day after the surgery, the patient had maculopapular wide spread itching rash.The patient was given hydrocart and fenergan iv.It was reported that after few hours, the patient felt slightly better.After the surgery, the patient started to have pain in inner thighs with difficulties to walk.The patient was given pain killers and it was reported the patient felt a bit better.The patient was sent home the next day after the surgery.When patient was at home, she still suffered from itching rash in her legs and a bit in her back.About 10 days after surgery, the rash turned more severe and changed appearance and skin urticaria was shown in the lower body as well in her back and shoulders.The patient also experienced bilateral edema in legs with walking difficulties.The patient was re-hospitalized, given hydrocorat and fenergan for 48 hrs and telfas pumi.It was reported that the dermatologist sent the patient home with prednisone and telfast pumi.It was reported that the patient feels better.It was reported that still now three weeks after surgery, the patient has a bit edema in thighs, itching rash, thigh pain and walking difficulties are improving.Additional information has been requested.

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: GYNECARE TVT OBTURATOR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8153648
• MDR Text Key: 130031340
• Report Number: 2210968-2018-77693
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 810081
• Device Lot Number: 3932091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR