MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH 20X25V; ABDOMINAL HERNIA SURGICAL MESH, COMPOSITE-POLYMER

Catalog Number PHY2025V

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

Patient Problems Adhesion(s) (1695); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Actual lot number of physiomesh device has been determined to be ja8bxhb0 from photo provided as jabbxhbc is not valid in the quality database.  to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? what was surgical approach (open, laparoscopic or other)? any concurrent surgeries or procedures? were pre-existing adhesions noted during the procedure? how were post-procedural adhesions confirmed? location and severity? please provide date and surgical findings of the viscerolysis of the small intestine.What is the relationship of adhesion to device implanted? if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? please confirm lot number for physiomesh as ¿ja88xhbq¿ is not in the system.Is it the actual lot "ja8bxhb0?" please confirm product code for securestrap device involved as ¿strap¿ is not in the system.Is it the strap15 or strap25? please confirm lot number for securestrap as ¿nnz195¿ does is not in the system.  a traceability sheet was received from the hospital on 18 march 2021 : date of the procedure : (b)(6) 2015.Procedure : eventration under laparoscopy with plate placement.Products : (1 ) unit code product phy2023v lot number jabbxhbc.(2) units code product strap25 lot number hhz195.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Event related to physiomesh device reported via mw #.Event related to first securestrap device reported via mw # 2210968-2021-02923.Event related to second securestrap device reported via mw # 2210968-2021-02924.

Event Description

It was reported that a patient underwent a video-surgery for diastasis on (b)(6) 2015 and the mesh was implanted.It was reported that the patient experienced unusual inflammatory adherence on the entire surface of the small intestine with a multi-adherent abdomen.It was also reported that the patient had a complete viscerolysis of the small intestine without prosthesis explantation.It was also reported that the patient had an occlusion after the implantation of the anti-adherent parietal prosthesis as well as multiple adherence of the small intestine.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 5/27/2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PHYSIOMESH 20X25V
• Type of Device: ABDOMINAL HERNIA SURGICAL MESH, COMPOSITE-POLYMER
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11597478
• MDR Text Key: 259330195
• Report Number: 2210968-2021-02922
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: PHY2025V
• Device Lot Number: JA8BXHB0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention