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); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Not Applicable (3189); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 12/30/2020.Additional h6 clinical codes: e1302, e0506, e1401, e2324.Additional information: a1, a2, b7.Additional b5 narrative: it was reported that the patient underwent mesh revision on (b)(6) 2020 due to vaginal bleeding, hematuria, discharge, urinary infections, urinary incontinence, leakage, necrotic tissue and scarring.

Manufacturer Narrative

Date sent to fda: 9/29/2020.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• 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
• MDR Report Key: 10579737
• MDR Text Key: 208324385
• Report Number: 2210968-2020-07241
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

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: 11/30/2007
• Device Catalogue Number: PFRT01
• Device Lot Number: 2987234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 09/24/2020; 12/29/2020
• Supplement Dates FDA Received: 09/29/2020; 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR