MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL; MESH, SURGICAL

Catalog Number PHY1520V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Urinary Frequency (2275); Not Applicable (3189)

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 surgery on (b)(6) 2012 and mesh was implanted.It was further reported that patient underwent an additional hernia repair procedure on (b)(6) 2013.No details are provided regarding the surgical procedures.It was reported that the patient experienced an undisclosed adverse event.No additional information was provided.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Additional patient code: (b)(4).It was reported that following procedure the patient experienced adhesion and infection.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Patient codes: (b)(4) - necrotizing abdominal wall fasciitis it was reported that the patient experienced abdominal pain, recurrent hernia, pain, nausea, vomiting, necrotizing abdominal wall fasciitis, fever, fatigue, and urinary frequency.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 05/13/2020.Additional narrative: it was reported that the patient underwent a mesh revision on (b)(6) 2013 due to recurrent incisional hernia.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7630858
• MDR Text Key: 112141921
• Report Number: 2210968-2018-73589
• 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: 10/08/2018

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: 07/31/2013
• Device Catalogue Number: PHY1520V
• Device Lot Number: DJ8BDXA0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 09/13/2018; 10/08/2018; 05/12/2020
• Supplement Dates FDA Received: 09/25/2018; 10/16/2018; 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR