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Adverse Event Report

DEPUY - NORTH BRUNSWICK DELTA-SPLINT SYNTH RL 4"X15FT CASTING PRODUCT   back to search results
Catalog Number 51143
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The complaint is for irritation and skin burns. The doctor may have applied the splint improperly. He used the same technique he used for plaster splint-casting. He was unsure if he followed ifu directions.

 
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
Manufacturer Narrative

Testing of the returned sample against the specification requirements for exotherm does not confirm the problem. Review of the device history records and the complaint database found no related problems. The root cause for this event is unk and the need for corrective action is not indicated. Monitor through trend analysis. Depuy considers the investigation closed at this time.

 
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Brand NameDELTA-SPLINT SYNTH RL 4"X15FT
Type of DeviceCASTING PRODUCT
Baseline Brand NameDELTA-SPLINT SYNTH RL 4"X15FT
Baseline Generic NameCASTING PRODUCT
Baseline Catalogue Number51143
Baseline Device FamilyDELTA SPLINT CASTING
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? Yes
Shelf Life(Months)NA
Date First Marketed03/23/2001
Manufacturer (Section F)
DEPUY - NORTH BRUNSWICK
casting products division
route #1, aaron road
north brunswick NJ 08902
Manufacturer (Section D)
DEPUY - NORTH BRUNSWICK
casting products division
route #1, aaron road
north brunswick NJ 08902
Manufacturer Contact
hans kusserow, mgr.
700 orthopaedic drive
warsaw , IN 46581-0988
(574) 372 -7416
Device Event Key388529
MDR Report Key399478
Event Key377500
Report Number1818910-2002-00359
Device Sequence Number1
Product CodeFYH
Report Source Manufacturer
Source Type Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number51143
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/23/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/17/2002
Device Ageunknown
Event Location Hospital
Date Manufacturer Received05/17/2002
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
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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