CRUTCH, FORMEARM ALUMINUMTALL A MDS805160 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2000-04-10 for CRUTCH, FORMEARM ALUMINUMTALL A MDS805160 * manufactured by Medline Industries, Inc..

Event Text Entries

[178818] Reportedly, the lock button on the forearm crutches gave way and they collapsed. Unknown who the mfr of the crutches is. Consequences to user are unknown user is not cooperative.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2000-00010
MDR Report Key273392
Report Source08
Date Received2000-04-10
Date of Report2000-04-07
Date Facility Aware2000-03-13
Report Date2000-04-07
Date Reported to FDA2000-08-03
Date Mfgr Received2000-03-14
Date Added to Maude2000-04-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLARA SIMMONS
Manufacturer StreetONE MEDLINE PL
Manufacturer CityMUNDELEIN IL 60060
Manufacturer CountryUS
Manufacturer Postal60060
Manufacturer Phone8479492639
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRUTCH, FORMEARM ALUMINUMTALL A
Generic NameCRUTCH
Product CodeIRP
Date Received2000-04-10
Model NumberMDS805160
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key264655
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressONE MEDLINE PL. MUNDELEIN IL 60060 US
Baseline Brand NameCRUTCH, FORMEARM ALUMINUMTALL A
Baseline Generic NameCRUTCH
Baseline Model NoMDS805160
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-04-10

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