MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO ADVANCED; MESH, SURGICAL, POLYMERIC

Model Number	UPA1015
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Inflammation (1932)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unspecified hernia repair procedure on an unknown date (years ago) and mesh was implanted.The patient reported the mesh is no longer at the right place, it disappeared and is now somewhere in the patient's body.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.What type of surgery did you have? what was the reason for this surgical procedure? please provide the date of surgery.Do you know the product code or lot number of the ultrapro advanced mesh used? what kind of symptoms are you experiencing? when did the issue begin? have you seen a physician or surgeon about this issue? if yes, what did they say about your condition? was a new surgery performed to correct your condition? if yes, date and name of the procedure? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: b3, d6a, h6 additional information received: hernia crack left side, 10x15 cm ethicon mesh was placed via laparoscopy, this was done in (b)(6) 2017, the surgery was not done properly, after 2 month the hernia crack appeared again.In 2021, a second surgery had to be done to fix the crack.A second mesh was placed by a specialist.This time, the hernia crack was fixed properly.The surgeon said that he could not find the first mesh (from the surgery in 2017) (b)(6) 2022, a tumor in the bladder was diagnosed and removed.Histology has shown that the tumor consists of an unspecific, chronical inflammation.It might be possible that the mesh migrated to the bladder and causing the chronical inflammation.

• Brand Name: ULTRAPRO ADVANCED
• 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; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16809952
• Report Number: 2210968-2023-02969
• Device Sequence Number: 14218843
• Product Code: FTL
• UDI-Device Identifier: 10705031236950
• UDI-Public: 10705031236950
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: UPA1015
• Device Catalogue Number: UPA1015
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 05/03/2023; 05/03/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/19/2023; 05/22/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown