MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT W/PRLNE BLUE MESH 1 EACH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number 810041B

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

Patient Problems Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).  the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.  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.  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2020 and the mesh was implanted.It was reported that from first day after surgery to date of discharge the patient's bladder would not void sufficiently (only 50ml at a time only).The patient was discharged with catheter.The patient experienced a lot of pain whilst catheterized.It was reported that one week later catheter was removed, but the bladder still could not void.The patient was instructed on how to self catheterize at home.It was reported that 18 hours later the patient was admitted into hospital emergency with a spasming bladder and the catheter was inserted again.The patient was instructed that catheter remain for another two weeks to enable bladder to recover, but the patient was still suffering a lot of pain with the catheter in situ.It was reported that two weeks later catheter was removed but the patient's bladder would still not void sufficiently, and the patient was instructed to self catheterize until the next appointment a week later.The patient was still suffering from pain after catheter was removed.The patient found self catheterization very painful and was not always successful in voiding due to inflammation at the top of the urethra and bottom bladder.The patient agreed to double or triple void instead.The patient returned to work after five weeks sick leave and the bladder function slowly improved over the following weeks with no leakage, but the patient still experienced a lot of pain making it very hard to sit, stand or walk.The pain the patient was experiencing became progressively worse to the point that the patient could not bear to walk, stand or sit.The patient could not lay on her side and it was very painful to travel in the car.The patient had visible swelling in the pubic area and inflammation around the urethra and vaginal area.The patient found that lying on the back was the only time the pain eases.It is reported that the patient had to take sick leave for another 5 weeks.Since the surgery the patient had done no exercise, walking, car traveling or anything more strenuous.It is reported that the patient's specialist prescribed amitriptyline cream and gabapentin to ease the pain and inflammation which helped to reduce both the pain and inflammation as long as the patient does not exert herself in anyway eg.The patient still cannot sit on a chair for any length of time, stand for too long, bend over to garden or walk any distance.It was reported that the pain the patient currently experiences (whilst medicated) is mainly in the vaginal area and between the vaginal wall and urethra.If the patient does anything too much she can experience a sharp pain in the vaginal area as if a razor blade had been inserted and she can feel area throbbing as if it is becoming inflamed.There is also some pain and a dragging feeling from the points of incision in the pubic area down and under the urethra exactly where the device is located.Prior to the medication the pain/inflammation was much worse and almost unbearable unless laying down.It was reported that the patient requires to sit in a cold salt bath morning and night and use a cold pack on genital area to ease the sense of throbbing.It is also reported that within hours of a specialist examination the pain and inflammation increases and takes approximately a week to settle down to where it was beforehand.

• Brand Name: GYNECARE TVT W/PRLNE BLUE MESH 1 EACH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11668951
• MDR Text Key: 245500437
• Report Number: 2210968-2021-03391
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K012628
• 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: 03/16/2021

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
• Device Expiration Date: 05/31/2022
• Device Model Number: 810041B
• Device Catalogue Number: 810041B
• Device Lot Number: 3934590
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention