MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA SYSTEM MESH::10X12CM OVAL UNDERLAY; MESH, SURGICAL, POLYMERIC

Catalog Number XCUHSOV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 12/01/2011

Event Type  Injury  

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.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.

Event Description

It was reported that the patient underwent an unknown surgical procedure on (b)(6) 2011 and the mesh was implanted.The patient experienced gastro problems accompanied with pain and at some point she passed out.The patient underwent an exploratory procedure to determine the issues and found that the device fell to the bottom.It was also reported that the device was removed on (b)(6) 2011 and replaced in the same procedure.She has also experienced bowel problems, problems having sex and decreased blood pressure.The patient is scheduled to have the mesh removal in (b)(6) 2019.Additional information has been requested.

Manufacturer Narrative

Patient code: 3191- gastrointestinal issues, bowel problems.It was reported that she experienced gastrointestinal issues, bowel problems.

Manufacturer Narrative

Date sent to the fda: 12/20/2020.Additional information: d6b.Additional b5 narrative: it was reported that the patient had removal surgery on (b)(6) 2011.Corrected information: d6a.Corrected b5 narrative: it was reported that the patient underwent an inguinal hernia repair surgery on (b)(6) 2011 and mesh was implanted.

Manufacturer Narrative

Date sent to the fda: 10/16/2020.Additional b5 narrative: it was reported that the patient underwent hernia repair on (b)(6) 2011 and mesh was implanted.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: ULTRAPRO HERNIA SYSTEM MESH::10X12CM OVAL UNDERLAY
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8403445
• MDR Text Key: 138220936
• Report Number: 2210968-2019-79357
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: XCUHSOV
• Device Lot Number: DB8CLGA0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention