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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Catalog Number CLR602US
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Evaluation: the analysis results found that a clr602us device was returned inside its package unopened. Upon visual inspection of the package, the foreign body was observed to be a hair. The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch. Although no conclusion could be reached on how the hair was introduced inside the sterile package, it is possible that the hair adhered to the device during the packaging process due to static.
 
Event Description
It was reported a patient underwent an unknown procedure, on (b)(6) 2019 and topical skin adhesive was used. During surgery, upon inspection before opening, customer noticed a hair inside sterile packaging. Case completed with another device of the same product code. There were no patient consequences reported.
 
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Brand NameDERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8912061
MDR Text Key155014634
Report Number2210968-2019-85848
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberCLR602US
Device Lot NumberPBQ177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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