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

Catalog Number	PHY1520V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Edema (1820); Inflammation (1932); Scarring (2061); Hernia (2240); Not Applicable (3189); 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.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.
Event or Problem Description
It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2011 and mesh was implanted.It was reported that the patient experienced abdominal pain and permanent scarring following surgery.It was reported that the patient underwent mesh removal on (b)(6) 2012.Other procedure is captured in a separate file.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: 10/30/2019.H6 patient codes: 3191 - menorrhagia.Additional b5 narrative: it was reported that the patient experienced menorrhagia, edema, and inflammation.
Additional Manufacturer Narrative
Date sent to the fda: 11/11/2024 additional information: d3 corrected information: d4 (primary udi #) additional b5 narrative: it was reported that the patient underwent repair of recurrent incisional hernia on (b)(6) 2012 and prolene mesh was implanted.Other procedure was captured in a separate file.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, 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: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 6107428552
• MDR Report Key: 8910930
• Report Number: 2210968-2019-85456
• Device Sequence Number: 1628067
• Product Code: FTL
• UDI-Device Identifier: 10705031132337
• UDI-Public: (01)10705031132337(17)110731(10)CH9KBZZ0
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• 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 Expiration Date: 07/31/2011
• Device Catalogue Number: PHY1520V
• Device Lot Number: CH9KBZZ0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 10/29/2019; 11/07/2024
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/30/2019; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 94 KG