MAUDE Adverse Event Report: ETHICON INC. TVT DEVICE W/BLUE MESH 3 PK; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 830041B

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Pain (1994); Ambulation Difficulties (2544)

Event Date 03/31/2004

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? 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?.

Event Description

It was reported by the patient that they underwent gynecological procedure on (b)(6)2004 and mesh was implanted.The patient reported the mesh snapped and failed after one year and the patient experienced resumption of symptoms of urinary incontinence proven by urodynamics.The patient reported they had a lot of gynecological surgery in a short period of time at that time and was reluctant to have more, especially with a young family.The patient began to experience symptoms of fatigue, back pain, abdominal pain and pain in groin such that patient was reluctant to engage in sexual relations with spouse.The patient reported the lethargy and joint pain was explored by rheumatologists and patient was diagnosed with fibromyalgia.The patient reported stabbing pain in lower left hand labia which is hard and painful, and patient reported concern that this is a hardened piece of mesh.The patient reported they suspect mesh has broken up and is puncturing outer labia and clitoral nerve.The patient is awaiting a translabial scan to confirm this.The patient reported constant bladder pain and a large ovarian cyst which is adhered to the bladder in such a way on ultrasound that patient suspects there is innovation with mesh, however this needs to be confirmed.The patient reported they suspect the mesh is adhered to chronic chocolate cyst on left ovary which is adhered in turn to patient¿s bladder and preventing patient from walking more than a very short distance or leaving the house.The patient reported they surmise this is from the pain they encounter and await an appointment with a specialist regarding removal of the mesh.Additional information has been requested.

• Brand Name: TVT DEVICE W/BLUE MESH 3 PK
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7320742
• MDR Text Key: 101767340
• Report Number: 2210968-2018-71324
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• 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: 02/06/2018

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 Catalogue Number: 830041B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/07/2018
• 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