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

Catalog Number PHY2030R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fatigue (1849); Pain (1994); Vomiting (2144); Hernia (2240); Injury (2348); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Patient code: (b)(4) - surgical intervention. Device problem: (b)(4) - hernia recurrence occurred. Additional narrative: it was reported that patient underwent mesh removal on (b)(6) 2015 by dr. (b)(6) at (b)(6) medical center due to recurrent hernia. No additional information was provided.

Manufacturer Narrative

It was reported that following insertion the patient experienced pain and abdominal pain.

Manufacturer Narrative

Patient codes: (b)(4). It was also reported that the patient experienced nausea, fatigue, infection, vomiting, ascites, constipation, and adhesions. It was also reported that the patient underwent mesh removal surgery on (b)(4) 2015. No additional information was provided.

Manufacturer Narrative

Date sent to fda: 7/1/2019.

Manufacturer Narrative

(b)(4). Undefined device problem. 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) 2014 and mesh was implanted. It was reported that the patient experienced an undisclosed adverse event. No additional information was provided.

• 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 08876 0151
• MDR Report Key: 7244527
• MDR Text Key: 107029969
• Report Number: 2210968-2018-70407
• 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,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/30/2015
• Device Catalogue Number: PHY2030R
• Device Lot Number: GP8DKPB0
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 02/06/2018 Patient Sequence Number: 1