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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 Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2021 and the mesh was used. Prior to surgery, the operating room nurse noticed when opening the foil that the foil was not properly sealed, and was already open in some places. There were no adverse patient consequences reported. Additional information was requested.
 
Manufacturer Narrative
Product complaint # (b)(4). Additional information was requested and the following was obtained: please provide procedure name and date; unknown. Please provide lot number; rjbddwc0. Please provide the return status of the device(s) as it has not been received for analysis. If the device has been shipped, please provide the shipment tracking details. Unknown.
 
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Brand NameUHS MESH 7.5CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13080108
MDR Text Key289447310
Report Number2210968-2021-12946
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K071249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUHSM1
Device Lot NumberRJBDDWC0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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