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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. UHS MESH 10X12 MESH, SURGICAL, POLYMERIC

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ETHICON INC. UHS MESH 10X12 MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UHSOV1
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria. Additional summary: a mesh device was returned for analysis. During visual inspection of the open sample, a side of mesh of underlay was partially detached from the flat undyed absorbable film. Per the condition of the sample, the assignable cause of performance loss of integrity - intra op is open welding edge, clearly missing weld defect. A photo was also returned for analysis and during the visual inspection of the picture/photo- a delaminated underlay could be observed. 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 was the procedure completed? any patient consequences? any patient demographics including initials, date of birth, age, wt, gender? provide contact names no one is listed in file?.
 
Event Description
It was reported that the patient underwent a herniorraphy on (b)(6) 2019 and the mesh was implanted. During the procedure, the mesh detachment found; it was reported that the patch and film was separated partly. Additional information has been requested.
 
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Brand NameUHS MESH 10X12
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 Key8439030
MDR Text Key139432409
Report Number2210968-2019-79589
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K071249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberUHSOV1
Device Lot NumberME8DDKB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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