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

Catalog Number PFRA01

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

Patient Problems Unspecified Infection (1930); Scarring (2061); Fibrosis (3167)

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 review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.(b)(4) represents the adverse event which occurred on (b)(6) 2007.(b)(4) represents the adverse event which occurred on (b)(6) 2009.(b)(4) represents the adverse event which occurred on (b)(6) 2012.(b)(4) represents the adverse event which occurred on (b)(6) 2014.

Event Description

It was reported by an attorney that the patient underwent a surgical procedure on (b)(6) 2006 and mesh was implanted into the patient.It was reported that the patient underwent revision on (b)(6) 2012.It was reported that following insertion the patient experienced bleeding, infection, fibrosis, scarring and urinary problems.No additional information was provided.

• Brand Name: ANTERIOR PELVIC FLOOR REPAIR S
• 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: 8762765
• MDR Text Key: 150109861
• Report Number: 2210968-2019-83622
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2006
• Device Catalogue Number: PFRA01
• Device Lot Number: 1343193
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2005
• 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: 53 YR