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Adverse Event Report

CLOSURE MEDICAL CORP. DERMABOND TOPICAL SKIN ADHESIVE TISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION   back to search results
Event Date 10/15/2003
Event Type  Other   Patient Outcome  Other;
Event Description

Product was applied to a forehead laceration on a pt. The product got into the child's right eye and the eye was bonded shut. A message was left for the initial reporter to return call and provide add'l specifics. At this time no add'l info has been provided. Product was not returned.

 
Manufacturer Narrative

Some info for this report had not been supplied at this filing. If the info is provided at a later date, a supplemental filing will be sent. Efforts have been made to acquire more relevant info but at the time of this filing none has been received. The event description does not suggest that the functional performance of the device was out of spec. The circumstances of this event indicate that user error caused the event. The directions for the use provided with the device in the package insert indicate that the adhesive must be applied gradually in layers and provides instructions on the positioning of the wound to avoid flow to unintended areas. The package insert warns that the product is a fast setting adhesive and includes add'l precautions to avoid unintended bonding in the area of the eye. Non clinical eye irritation studies included in the approved pma for this device conclude that the application of the adhesive to the eye results in no permanent damage, but can produce a mild irritation to the conjunctiva.

 
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Brand NameDERMABOND TOPICAL SKIN ADHESIVE
Type of DeviceTISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CLOSURE MEDICAL CORP.
5250 greens dairy rd.
raleigh NC 27616
Manufacturer (Section D)
CLOSURE MEDICAL CORP.
5250 greens dairy rd.
raleigh NC 27616
Manufacturer (Section G)
CLOSURE MEDICAL CORPORATION
5250 greens dairy road
raleigh NC 27616
Manufacturer Contact
w. stephens, director
5250 greens dairy rd.
raleigh , NC 27616
(919) 876 -7800
Device Event Key486975
MDR Report Key498230
Event Key472430
Report Number1034548-2003-00025
Device Sequence Number1
Product CodeMPN
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 11/25/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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