MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 6INX6IN; MESH, SURGICAL, POLYMERIC

Model Number	SPMH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Inflammation (1932); Nausea (1970); Pain (1994)
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 hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent revision surgery due to pain and recurrence on an unknown date.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation and loss of appetite.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: (b)(6) 2020.Additional information: a2, b7, d3, g1, g2.
Additional Manufacturer Narrative
Date sent to the fda: 08/22/2022.Additional b5 narrative: it was reported that following the procedure the patient experienced lysis of adhesions and abdominal pain.
Additional Manufacturer Narrative
Date sent to the fda: 08/24/2022.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROLENE SOFT MESH 6INX6IN
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km. 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 9510801
• Report Number: 2210968-2019-90796
• Device Sequence Number: 1410071
• Product Code: FTL
• UDI-Device Identifier: 10705031050464
• UDI-Public: 10705031050464
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K962530
• 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,Followup
• Report Date (Section B): 12/11/2019

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: 07/31/2017
• Device Model Number: SPMH
• Device Catalogue Number: SPMH
• Device Lot Number: EME844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 11/09/2020; 08/22/2022; 08/23/2022
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 11/10/2020; 08/22/2022; 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2012
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 130 KG