MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO COMFORT PLUG 55MM; MESH, SURGICAL, POLYMERIC

Model Number	UPLUG553
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994); Hernia (2240); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.(b)(4) submitted for the adverse event which occurred on (b)(6) 2017.(b)(4) submitted for the adverse event which occurred on (b)(6) 2019.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Event or Problem Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2016 and ultrapro comfort plug was implanted.It was reported the patient underwent revision surgery on (b)(6) 2017.It was reported the patient underwent revision surgery on (b)(6) 2019.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 4/25/2023.Additional b5 narrative: it was reported that the patient experienced hernia recurrence, discomfort, nausea, and pain.

• Brand Name: ULTRAPRO COMFORT PLUG 55MM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• 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
• MDR Report Key: 11935749
• Report Number: 2210968-2021-05249
• Device Sequence Number: 19624554
• Product Code: FTL
• UDI-Device Identifier: 10705031228474
• UDI-Public: 10705031228474
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 05/27/2021

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: 03/31/2018
• Device Model Number: UPLUG553
• Device Catalogue Number: UPLUG553
• Device Lot Number: KD8BTTP0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 04/23/2023
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• 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: Male