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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. UHS MESH 7.5CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. UHS MESH 7.5CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UHSM1
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Date sent to the fda: 10/18/2018. 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. It was reported that during use, the onlay patch was slightly broken at the underlay patch. Please indicate if the device was torn, frayed, separating and falling apart? it was reported that the patient's outcome was not good after device use, please elaborate and describe what the patient's experience was, that was not good, what was the negative consequence the patient experienced? please provide the following: name of procedure?; did event occur intra-op?; how was the procedure completed? provide lot number, only the actual lot number of the device used for this procedure? patient demographics if available: pt's initials, date of birth, age, wt at time of surgery.
 
Event Description
It was reported that the patient underwent an unknown procedure on an unknown date and mesh was used. During use, it was found that the onlay patch was slightly broken at the underlay patch, and the patient's outcome was not good after use, so it was discarded and could no longer be used. There were no adverse patient¿s consequences reported. Additional information has been requested.
 
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Brand NameUHS MESH 7.5CM
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
p.o. box 1409 d22841
norderstedt
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7979406
MDR Text Key124374590
Report Number2210968-2018-76620
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K071249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUHSM1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2018
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

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