MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

Catalog Number	UMS3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: weight, bmi at the time of index procedure.The initial approach for the index surgical procedure? other relevant patient history/concomitant medications reported lot lk8c2rxo is invalid.Please provide valid lot#.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-intra- or post-operation? were cultures performed? results? please provide surgical findings of second surgery (b)(6) 2018.Was the mesh removed completely? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
Event or Problem Description
It was reported that the patient underwent a bilateral inguinal hernia repair procedure on (b)(6) 2018 and the mesh was implanted.On (b)(6) 2018, bilateral groin incision abscess was obvious, the incision opened and a large amount of purulent fluid came out.The patient underwent a second surgery on (b)(6) 2018 to remove the mesh and medicine was used on incision.It was reported that now the patient status is stable.Additional information has been requested.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7834225
• Report Number: 2210968-2018-75544
• Device Sequence Number: 1338617
• Product Code: FTL
• UDI-Device Identifier: 10705031132504
• UDI-Public: 10705031132504
• Combination Product (Y/N): N
• PMA/510(K) Number: K033337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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 Catalogue Number: UMS3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR