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

Catalog Number PFRT01

Device Problem Migration (4003)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Incontinence (1928); Inflammation (1932); Lupus (1956); Urinary Tract Infection (2120); Urinary Frequency (2275); Blood Loss (2597)

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 an unknown gynecological procedure on (b)(6) 2010 and the mesh was implanted.It was also reported that the mesh was causing subsequent pelvic injuries including a foreign body response of inflammation and the subsequent development of systemic lupus erythematosis, mesh erosion in vagina with bleeding, contracture of the mesh causing severe narrowing of the vagina and making sexual intercourse impossible, urinary frequency with some urge incontinence and frequent urinary tract infections.No further information is available.

• 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
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8139913
• MDR Text Key: 129574909
• Report Number: 2210968-2018-77574
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2018

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 Expiration Date: 07/31/2012
• Device Catalogue Number: PFRT01
• Device Lot Number: 3342445
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention