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 Unspecified Infection (1930); Scarring (2061); Swelling (2091)

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.In addition, a device history review has been inserted into the file. this review indicates that there was no quality concerns associated with the manufacturing process.(b)(4) submitted for adverse event which occurred on (b)(6) 2006.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.

Event Description

It was reported by an attorney that the patient underwent a surgical procedure on (b)(6) 2006 and mesh was implanted.It was reported that following insertion the patient experienced scarring, infection, swelling, inflammation and urinary problems.It was reported that patient underwent revision of mesh on (b)(6) 2006 and (b)(6) 2017.No additional information was provided.

• 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; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8704668
• MDR Text Key: 148193749
• Report Number: 2210968-2019-82702
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2019

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: 03/31/2007
• Device Catalogue Number: PFRT01
• Device Lot Number: 2904435
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2006
• 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
• Patient Age: 44 YR