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Adverse Event Report

CARDINAL HEALTH GLOVE PROTEGRITY SMT PF LATEX SURG 7.5 SURGEON GLOVE   back to search results
Catalog Number 2D72NS75
Event Date 08/09/2004
Event Type  Other   Patient Outcome  Other;
Event Description

Dr went to put his right hand into the glove and suddenly felt pain. There was something that looked like a piece of chrome stuck in his ring finger. He extricated the piece himself, washed his hands, and proceeded with the case.

 
Manufacturer Narrative

One pair of gloves was returned in a package. Two pieces of metal ch1820334ips were observed to be stuck to the inner wrap of the glove. The chips wer2004e ruled out to be aluminum. The exact cause of the defect could not be 512q established. However, the probable source of the metal chips could be either the cutting horns or the conveyor roller. All cutting horns at packaging were inspected. Sharp edges were observed in 8 and were replaced immediately. Packaging has one set of conveyor roller with chrome plating. The conveyor rollers were checked and found to be in good condition. This appears to be an isolated incident. We will continue to monitor for unfavorable trends, which might require further investigation.

 
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Brand NameGLOVE PROTEGRITY SMT PF LATEX SURG 7.5
Type of DeviceSURGEON GLOVE
Baseline Brand NameGLOVE PROTEGRITY SMT PF LATEX SURG 7.5
Baseline Generic NameSURGEON GLOVE
Baseline Catalogue Number2D72NS75
Baseline Model Number2D72NS75
Baseline Device FamilyPROLEGRITY SMT SURGICAL GLOVE
Baseline Device 510(K) NumberK001924
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed07/14/2000
Manufacturer (Section F)
CARDINAL HEALTH
mcgaw park IL *
Manufacturer (Section D)
CARDINAL HEALTH
mcgaw park IL *
Manufacturer Contact
michele donatick
1430 waukegan road, bldg kb
mcgaw park , IL 60085
(847) 785 -3309
Device Event Key531379
MDR Report Key542030
Event Key514744
Report Number1423507-2004-00087
Device Sequence Number1
Product CodeKGO
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/02/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number2D72NS75
Device LOT NumberTS0309355
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/17/2004
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/09/2004
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2003
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? No Answer Provided
Type of Device Usage Initial

Database last updated on January 06, 2009

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