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); Adhesion(s) (1695); Hernia (2240); Swelling/ Edema (4577); 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) 2014 and mesh was implanted.It was reported that the patient experienced abdominal pain, gastrointestinal malfunction, grotesque swelling, and hernia recurrence, and additional surgery on (b)(6) 2019.No additional information was provided.
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.
Additional Manufacturer Narrative
Date sent to the fda: 12/13/2022.Additional b5 narrative: it was reported that following the procedure, patient experienced extensive lysis of adhesions.

• 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: 15689882
• Report Number: 2210968-2022-08895
• Device Sequence Number: 7359436
• Product Code: FTL
• UDI-Device Identifier: 10705031132313
• UDI-Public: 10705031132313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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 Model Number: PHY1515Q
• Device Catalogue Number: PHY1515Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 12/11/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female