MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 20X30CM RECT; MESH, SURGICAL

Catalog Number PHY2030R

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

Patient Problems Adhesion(s) (1695); Pain (1994); Cramp(s) (2193); Hernia (2240); Injury (2348); Not Applicable (3189); No Code Available (3191)

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 hernia repair procedure on (b)(6) 2013 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 5/1/2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to fda: 4/17/2020.H6 patient code: 3189 - surgical intervention.Additional information: a1, a2, d3, d7, g1, g2.Additional b5 narrative: it was reported that the patient experienced recurrent hernia, adhesions following surgery.It was reported that the patient underwent hernia repair surgery on (b)(6) 2017.

Manufacturer Narrative

Date sent to the fda: 4/27/2020.Additional h6 patient code: 3191 - irritable bowel syndrome.Additional b5 narrative: it was reported that the patient experienced constant pain, cramping and irritable bowel syndrome following surgery.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 20X30CM RECT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9574595
• MDR Text Key: 185896931
• Report Number: 2210968-2020-00241
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2020

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: 08/31/2015
• Device Catalogue Number: PHY2030R
• Device Lot Number: GK8DMJA0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 04/17/2020; 04/26/2020; 04/30/2020
• Supplement Dates FDA Received: 04/17/2020; 04/27/2020; 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR