MAUDE Adverse Event Report: ETHICON INC. TOTAL PELVIC FLOOR REPAIR SYST; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRT01

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

Patient Problems Fistula (1862); Granuloma (1876); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)

Event Date 02/02/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.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.

Event Description

It was reported that the patient underwent a prolapse surgical procedure possibly in 2009 or 2010 and the mesh was implanted.As reported, the patient was examined in 2014 and presented repetitive infections for 7 months, dyspareunia and pelvic pain.The vaginal examination was very painful, a retroverted retroflexed uterus and one anterior interstitial myoma 15 mm were noted.There were found thickened anterior vaginal wall and irregular anterior prosthesis in favor of anterior retraction marked central level.It was reported that impression of anterior arm of the intra vesical prosthesis was transfixing on the right side and a fine and regular prosthesis on the posterior vaginal wall.Calcification just above the right pubic ilium branch, fistulated into the bladder, was found.The patient experienced pain, recurrent/recidive rectal prolapse, anal incontinence sometimes, vesical ureteral right vaginal fistula and very difficult exemption sometimes.On (b)(6) 2014, anterior vaginal resection along with sinuous fistulous tract removal of two fragments of fistulated material was performed.Vaginal fragment was 20 and 25mm and other one in the bladder was 12 and 30mm.It was also reported that in both cases, there was a resorptive macrophage granuloma with foreign body.

Manufacturer Narrative

Concomitant medical products: monarc subfascial hammock.

• Brand Name: TOTAL PELVIC FLOOR REPAIR SYST
• 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: 8584923
• MDR Text Key: 144246427
• Report Number: 2210968-2019-81092
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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: 01/31/2011
• Device Catalogue Number: PFRT01
• Device Lot Number: 3120328
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 05/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR