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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMII
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  No Answer Provided  
Manufacturer Narrative
(b)(4). Date sent to the fda: 12/15/2016. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods/final inspection release criteria. Attempts have been made to retrieve the device. 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. 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.
 
Event Description
It was reported that the patient underwent an unknown procedure on unknown date and the mesh was implanted. It was also reported that there was a wrong label of the product. Additional information has been requested.
 
Manufacturer Narrative
Additional information was requested and the following was received: is the problem related to the correct product in the packaging however incorrect labeling? the product was in the paper envelope with the correct size, however in the sterile packaging the size is incorrect. Is the problem related to incorrect product mix in the packaging? the product was in the paper envelope with the correct size, however in the sterile packaging the size is incorrect. What is the quantity involved? n/i.
 
Manufacturer Narrative
In the visual inspection by sample, it was identified: the label on the box is different from the label on the envelope. According the condition of the sample, it was found "wrong and/or mixed labels". An investigation has been initiated to address the potential root cause.
 
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Brand NamePROLENE POLYPROPYLENE MESH
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.-BRAZIL
rodovia presidente dutra, km 1
54
sao paolo 12240 -908
BR 12240-908
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6178229
MDR Text Key62531584
Report Number2210968-2016-15517
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue NumberPMII
Device Lot NumberAF9682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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