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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PVPM
Device Problem Material Fragmentation (1261)
Patient Problems Foreign Body Reaction (1868); Not Applicable (3189)
Event Date 07/11/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at 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. The patient demographic info: age, weight, bmi at the time of index procedure date and name of initial surgical procedure: the diagnosis and indication for the initial surgical procedure? can you provide more details on reaction that occurred? are photos of reaction available? how long after initial procedure was reaction noted? describe any medical/surgical intervention including reason, dates and surgical findings. Other relevant patient history/concomitant medications: what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status?.
 
Event Description
It was reported that the patient underwent an unknown surgical procedure on unknown date and the mesh was implanted. Two weeks later, the patient experienced unclear reactions after surgery and the mesh was explanted. The surgeon found that the ring of implant had broken into many small pieces. It was also reported that the patient currently is well. Additional information has been requested.
 
Manufacturer Narrative
Pc-(b)(4). Date sent to the fda: (b)(4) 2018. A used proceed ventral patch of product code (b)(4) was returned for analysis. During the visual inspection of sample, body fluids and a tissue of 1. 75¿ of length was noted on the ventral patch. The ventral patch has begun with degradation process; since, there are fragments of the pds base plate on the sample and the tissue. Per the condition of sample received, it could not be determined what may have caused the reported incident.
 
Manufacturer Narrative
Date sent to the fda: (b)(4) 2018. Additional information:- the actual device batch number associated with this event is not known. As per health authority request, the international affiliate reports the following possible distributed batch numbers : (b)(4) batch# (b)(4). Mfg. Date: (b)(4) 2017; exp. Date: (b)(4)/2019 batch# (b)(4) mfg. Date: (b)(4) 2018; exp. Date: 1(b)(4) 2019 in addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.
 
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Brand NamePVP MEDIUM 6.4CM X 6.4CM
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.-GMBH
robert-koch strasse 1
norderstedt
GM
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7722872
MDR Text Key115121394
Report Number2210968-2018-74639
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K061533
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 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPVPM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2018
Was Device Evaluated by Manufacturer? Yes
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: 07/26/2018 Patient Sequence Number: 1
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