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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE*SOFT POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE*SOFT POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number SPMII
Device Problem Migration (4003)
Patient Problem Not Applicable (3189)
Event Date 08/01/2017
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. How are you currently feeling? 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.

 
Event Description

It was reported that the patient underwent an unknown surgical procedure on (b)(6) and the mesh was implanted. The patient had a subsequent surgery on (b)(6) for migration. Second mesh implanted was bard mesh. Third procedure for same issue is needed. Additional information has been requested.

 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8259608
MDR Text Key133464610
Report Number2210968-2019-78480
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 12/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSPMII
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/17/2019 Patient Sequence Number: 1
Treatment
BARD MESH
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