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

Model Number	PHY2030R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported by an attorney the patient underwent an incisional hernia repair surgery on (b)(6) 2013 and mesh was implanted (20 x 20 piece of mesh) operative note was provided which noted ¿a large amount of omentum was taken down from the left lower quadrant hernia site.¿ it was reported a suture was placed at each of the four corners of the mesh and was then inserted into the abdomen and unrolled.It was reported the surgeon then used a suture passer to pull the sutures to the exterior surface and each were tied into place.The mesh was then circumferentially tacked around the hernia defect to provide a good seal.It was reported the patient underwent ventral hernia repair on (b)(6) 2014 and the surgeon noted large ventral hernia and hernia sac and ¿care was taken to dissect the adhesions and hernia sac free.¿ the skin and subcutaneous tissue was freed for approximately 9 cm in both directions, laterally.Mesh was sutured into place in 4 quadrants and ¿then in between each initial tacking suture, until this was well secured.¿ additional overlay mesh was also tacked over the primary and synthetic mesh repairs.It was reported that the patient underwent repair of recurrent incisional hernia with mesh and component separation on (b)(6) 2014 and the surgeon noted ¿the mesh could be seen pulled out and away from its inferior position¿ which was removed in its entirety.No additional information is reported at this time.
Additional Manufacturer Narrative
Date sent to fda: 8/1/2018 additional information: in addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
Additional Manufacturer Narrative
Date sent to fda: 04/16/2020.Additional narrative: it was reported that the patient underwent mesh revision with new implant on (b)(6) 2014.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 20X30CM RECT
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7687556
• Report Number: 2210968-2018-74358
• Device Sequence Number: 1316352
• Product Code: FTL
• UDI-Device Identifier: 10705031132351
• UDI-Public: 10705031132351
• Combination Product (Y/N): N
• Initial Reporter State: LA
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: PHY2030R
• Device Catalogue Number: PHY2030R
• Device Lot Number: GE8CTKA0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 04/15/2020
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/01/2018; 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR