MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH 15X15QÂ Â Â; MESH, SURGICAL

Model Number	PHY1515Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an attorney that the patient underwent a hernia repair surgery (b)(6) 2013 and mesh was implanted.It was reported that the patient experienced undisclosed adverse events.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 08/30/2022 (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.
Additional Manufacturer Narrative
Date sent to the fda: 11/06/2022.It was reported that the patient underwent partial removal of mesh on (b)(6) 2015 due to infected mesh with abdominal wall abscess.It was reported that the patient experienced severe abdominal pain.Mwr-04112022-0001292339 submitted for adverse event which occurred on (b)(6) 2015.Mwr-04112022-0001292341 submitted for adverse event which occurred on (b)(6) 2016.
Additional Manufacturer Narrative
Date sent to the fda: 11/11/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: ETHICON PHYSIOMESH 15X15QÂ Â Â
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15325316
• Report Number: 2210968-2022-07114
• Device Sequence Number: 6314577
• Product Code: FTL
• UDI-Device Identifier: 10705031132313
• UDI-Public: 10705031132313
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/30/2022

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: PHY1515Q
• Device Catalogue Number: PHY1515Q
• Device Lot Number: GE8BDDA1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 11/09/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/06/2022; 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male