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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 Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). 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.
 
Event Description
It was reported by the rep during inventory inspection it was found that the packages all had cracks on the corner of the packaging and there was a concern for the sterility of the product. Samples will be returned.
 
Manufacturer Narrative
Product complaint # (b)(4). Additional information: a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Additional evaluation summary: the sample was returned for evaluation. The analysis results found that the device was returned inside its package unopened. Upon visual inspection of the device, it was observed that the blister tray of the returned unit was broken in one of the corners. The pen device was observed to be without damages. The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch. Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage.
 
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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 NJ 08876 0151
MDR Report Key8136330
MDR Text Key129455417
Report Number2210968-2018-77549
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue NumberCLR222US
Device Lot NumberMJH576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Is This a Reprocessed and Reused Single-Use Device?

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