MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH 15X15Q; MESH, SURGICAL

Catalog Number PHY1515Q

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Inflammation (1932); Necrosis (1971); Pain (1994); Perforation (2001); Septic Shock (2068); Seroma (2069); Injury (2348); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 hernia repair surgery on (b)(6) 2015 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: 3/5/2021.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: (b)(6) 2021.Additional information: a1, a2, b2, d1, d2a, d4.H6: appropriate term / code not available (e2402) utilized to capture infection (e19).Additional b5 narrative: it was reported that the patient had a revision surgery on 8/4/2015.It was reported that the patient experienced bowel perforation, intra abdominal abscess, fascial dehiscence, septic shock, edematous subcutaneous tissues, copious adhesion, fibrinous exudate, fat necrosis, infection, inflammation, pain and seroma.

• Brand Name: PHYSIOMESH 15X15Q
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10649576
• MDR Text Key: 210437483
• Report Number: 2210968-2020-07716
• 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
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: PHY1515Q
• Device Lot Number: HM8GCMB1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention