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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PCDJ1
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problems Foreign Body Reaction (1868); Not Applicable (3189)
Event Date 01/19/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. The following information has been requested, but no information has been received. Should additional information be provided, a 3500a supplemental will be submitted: the patient demographic info: age, gender, weight, bmi at the time of index procedure. Name of index surgical procedure. The diagnosis and indication for the index surgical procedure? what were current symptoms following the index surgical procedure? what were the symptoms that lead to the diagnosis of rejection? other relevant patient history/concomitant medications. 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 current status?.

 
Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and mesh was implanted. The patient presented rejection on the following postoperative day. The mesh was removed on (b)(6) 2018. Additional information will be requested.

 
Manufacturer Narrative

A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

 
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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.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7320584
MDR Text Key101732809
Report Number2210968-2018-71323
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device Catalogue NumberPCDJ1
Device LOT NumberKPG331
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/07/2018 Patient Sequence Number: 1
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