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); Pain (1994)

Event Date 02/25/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Patient-reported adverse events for two other meshes implanted on (b)(6) 2005 were submitted via following medwatch reports: 2210968-2020-01254 and 2210968-2020-01258.

Event Description

It was reported that the patient underwent a surgical procedure for pelvic floor prolapse including bladder and bowel incontinence on (b)(6) 2005 and the unknown mesh was implanted.Over the years, the patient experienced high inflammation blood markers, regular bladder infections and significant abdominal pain regularly.It was also reported that the patient saw a specialist for the swelling and pain in abdomen and this was put down to dietary allergies without testing.Recently, the patient experienced constant infection and stabbing pain.As per patient, because she is t11/12 paraplegic, sensation in the abdomen is not a true indication of what is happening and typically, she is receiving pain signals when pain is at its worst.No further information is available.

Manufacturer Narrative

Date sent to the fda: 03/13/2020.Lot 1332543 was unavailable for review therefore an assessment memo was attached for product code pfra01.

• 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
• MDR Report Key: 9723156
• MDR Text Key: 185942719
• Report Number: 2210968-2020-01256
• 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,other
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2006
• Device Catalogue Number: PFRA01
• Device Lot Number: 1332543
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Patient Sequence Number: 1