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

Catalog Number	PHY1520R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Inflammation (1932); Pain (1994); Swelling (2091); Hernia (2240); No Code Available (3191)
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 that the patient underwent a hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that on (b)(6) 2014, the patient presented to (b)(6) hospital for corrective surgery due to a recurrent hernia.During the procedure, dr.(b)(6) found that the bottom of the mesh was pulled loose and there were bowels slipped under the mesh to get into the hernia.Dr.(b)(6) implanted a new 10 x 15 cm mesh.On (b)(6) 2015 he underwent repair of the mesh at (b)(6).It was reported that the patient continues to experience pain, nausea, diarrhea, chills, inflammation, loss of appetite and weight loss.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: 7/11/2019.Additional narrative: it was reported that the patient experienced adhesion, abdominal pain after the procedure.
Additional Manufacturer Narrative
Date sent to fda: 10/30/2019.Additional narrative: it was reported that the patient had recurrent right inguinal hernia on (b)(6) 2014.It was reported that the patient experienced swelling and migration of mesh.(b)(4) submitted for adverse event which occurred on (b)(6) 2014.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM 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: 7539692
• Report Number: 2210968-2018-72535
• Device Sequence Number: 18863466
• Product Code: FTL
• UDI-Device Identifier: 10705031132320
• UDI-Public: 10705031132320
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2019

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 Catalogue Number: PHY1520R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 07/10/2019; 10/29/2019
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/11/2019; 10/30/2019
• 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