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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problems Device Expiration Issue (1216); Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Pc(b)(4).
 
Manufacturer Narrative
Product complaint # pc-(b)(4). Correction h-3 evaluation summary - an evaluation by photo was performed. Batch lkh207 was manufactured on (b)(4) 2017 and the correct expiry date is (b)(4) 2019. The shelf box labeling showed correct expiration date of 2019 but the label in the tyvek has (b)(4) 2012 (incorrect). This is considered as incorrect and/or missing labelling condition.
 
Manufacturer Narrative
(b)(4). Evaluation summary ¿ an evaluation by photo was performed. Batch (b)(4) was manufactured on 10/04/2017 and the correct expiry date is 08/31/2019. The shelf box labeling showed correct expiration date of 2019 but the label in the tyvek has 08/31/2012. This is considered as incorrect and/or missing labelling condition. The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form. A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event Description
It was reported that an expired topical skin adhesive product was received. The expiration date on the contents is (b)(6) 2012. There were no patient consequences reported.
 
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Brand NameDERMABOND PRINEO 22CM SKIN CLOSURE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC. SAN LORENZO
road 183, km. 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7143867
MDR Text Key105926396
Report Number2210968-2017-71940
Device Sequence Number1
Product Code OMD
UDI-Device Identifier10705031230996
UDI-Public10705031230996
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/16/2019
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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