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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 Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified. Additional information was requested and the following was obtained: please confirm that the item torn was the packaging and not the mesh? - returning 2 product complaints with same lot from same account and same case. Yes, 1 torn with mesh and second product had packaging issues with no mesh. If the mesh was torn, did it occur when the circulating nurse opened the device packaging to put device on sterile field? -unknown for both. If issue is confirmed to be the packaging torn and not the mesh provide the following: was the primary package torn exposing the device compromising device sterility? - unknown. How did the packages containing the devices tear? -unknown. Did the circulating nurse have difficulty opening the primary package? -unknown. Did the packaging not open correctly, not opening at the seal but tearing the primary package when staff attempted to open? -unknown. Indicate how procedure was completed? -used another piece of mesh. Any patient consequences? -none. Status of device return? if shipped back for evaluation, provide tracking number? -yes, both products will be returned. Evaluation: an opened foil packet of product was returned for analysis. During the visual inspection of the opened sample, the top foil packet was observed torn. A functional test was performed on packet and the seal strength force met the requirement. Per the sample conditions, it could not be determined what may have caused the reported incident.
 
Event Description
It was reported that the patient underwent a hernia repair on (b)(6) 2019 and the mesh was implanted. Prior to surgery, the device was taken out of the plastic container and it was noted that a foil package was torn, no issue with the mesh. There were no patient consequences reported. Another like device was used to complete the procedure.
 
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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
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8485768
MDR Text Key141207953
Report Number2210968-2019-80036
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue NumberUHSOV1
Device Lot NumberMJ8GBKB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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