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Adverse Event Report

BECTON DICKINSON CONSUMER PRODUCTS ACE BRAND REUSABLE COLD COMPRESS   back to search results
Catalog Number 207516
Event Date 08/22/1996
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

After applying a reusable cold compress to her buttocks, she suffered 2nd and 3rd degree burns according to her doctor. She also claims she has been unable to wear clothes for eleven days because of this event.

 
Manufacturer Narrative

This medical device report is submitted by becton dickinson and co in complaince with21 cfr part 803. The submission of information pursuant to this rule, or public release of such info by fda or any other party does not constitute an admission that a device has malfunctioned or establish the existence of any causal connection between a produt and a death or injury.

 
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Brand NameACE BRAND REUSABLE COLD COMPRESS
Type of DeviceCOLD COMPRESS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BECTON DICKINSON CONSUMER PRODUCTS
one becton dr
franklin lakes NJ 07417
Manufacturer (Section D)
BECTON DICKINSON CONSUMER PRODUCTS
one becton dr
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON CONSUMER PRODUCTS
one becton dr.
franklin lakes NJ 07417 1883
Device Event Key41543
MDR Report Key40434
Event Key37900
Report Number2242453-1996-00001
Device Sequence Number1
Product CodeIME
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 09/05/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number207516
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Invalid Data
Date Manufacturer Received09/05/1996
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 06, 2009

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