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Adverse Event Report

H & P INDUSTRIES, INC. TRIAD LEMON GLYCERINE SWABS   back to search results
Catalog Number 10 4002
Event Description

Complaints by staff member that glycerine swabs looked "moldy". Visual exam of various packets showed a range of color from white to grey. Package seemed to be sealed but damp.

 
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Brand NameTRIAD
Type of DeviceLEMON GLYCERINE SWABS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
H & P INDUSTRIES, INC.
600 perkins dr.
mukwonago WI 53149
Device Event Key192436
MDR Report Key198088
Event Key186137
Report NumberMW1015011
Device Sequence Number1
Product CodeKXF
Report Source Voluntary
Report Date 11/19/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10 4002
Device LOT Number8H 241
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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