MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO PLUG (MEDIUM); MESH, SURGICAL, POLYMERIC

Model Number	UPPM6
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an inguinal hernia repair on an unknown date and the mesh was implanted.It was reported that the patient experienced a recurring hernia five years post op.It was reported that the original mesh was completely gone, but the mesh fixation suture was visible.It was also reported that the mesh disappeared.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of initial surgical procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications was the hernia repair associated with this event performed on primary or recurrent hernia? what was the defect size/type/location of the hernia associated with this event? mesh size and overlap? was the procedure associated with this event open or laparoscopic? if applicable in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or intra-abdominal) if applicable, closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? if applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants) were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? e.G.Graspers crimping the mesh fibers was there any triggering event prior to present recurrence? (e.G.Weight gain, sneezing, coughing, strenuous activity)? how was the recurrence diagnosed? please provide surgical findings if reoperation was conducted.Are there any pictures available? product lot # if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

• Brand Name: ULTRAPRO PLUG (MEDIUM)
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12724035
• Report Number: 2210968-2021-10610
• Device Sequence Number: 3706667
• Product Code: FTL
• UDI-Device Identifier: 10705031132597
• UDI-Public: 10705031132597
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: GM
• PMA/510(K) Number: K070224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: UPPM6
• Device Catalogue Number: UPPM6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 11/29/2021; 11/29/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 11/29/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown