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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. ULTRA PRO MESH MESH, SURGICAL, POLYMERIC

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ETHICON, INC. ULTRA PRO MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 263289
Device Problems Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2019
Event Type  Malfunction  
Event Description

Had hernia repair in (b)(6) 2018. Discovered in (b)(6) 2019 that hernia had returned in same place. Suspect that the mesh used failed. Mesh used was ultra pro, ethox corp, partial absorbable, 6x6, log # 263289. Need new repair. Heard there is a recall on this product and that a class action lawsuit is in progress. Dr (b)(6) diagnosed the need for another repair. Fda safety report id# (b)(4).

 
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Brand NameULTRA PRO MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON, INC.
MDR Report Key9086859
MDR Text Key159407658
Report NumberMW5089890
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number263289
Device Catalogue Number263289
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/18/2019 Patient Sequence Number: 1
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