JAY SEATING J2 BACK NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-10-06 for JAY SEATING J2 BACK NA manufactured by Sunrise Medical, Mpd.

Event Text Entries

[15740491] Reporter states both top adjusters fractured. End user states that on april 27, 2000, end user reclined the chair at approximately 12:30 p. M. And within a few seconds the j2 bracket on the right side broke from the j2 backrest and end user fell out the back of the chair striking the head on the floor. As a result of the fall end user was stuck on the floor for a few hours until 2:53 p. M, when someone found end user. End user had a swollen red ankle where the right leg rested in the frame of the chair, a bruised hip, ribcage and knuckles, pulled biceps, open skin on their elbow and a sore neck.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1720745-2000-00008
MDR Report Key299245
Report Source00
Date Received2000-10-06
Date of Report2000-10-05
Date of Event2000-04-27
Date Mfgr Received2000-09-07
Date Added to Maude2000-10-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationSERVICE PERSONNEL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactWENDY CAVANAUGH
Manufacturer Street2842 BUSINESS PARK AVE
Manufacturer CityFRESNO CA 93727
Manufacturer CountryUS
Manufacturer Postal93727
Manufacturer Phone5592922171
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRL
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameJAY SEATING
Generic NameWHEELCHAIR, ACCESSORY
Product CodeKNO
Date Received2000-10-06
Returned To Mfg2000-09-20
Model NumberJ2 BACK
Catalog NumberNA
Lot NumberP/N 25161K
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key289664
ManufacturerSUNRISE MEDICAL, MPD
Manufacturer Address7477 DRY CREEK PKWY LONGMONT CO 80503 US
Baseline Brand NameJAY SEATING
Baseline Generic NameWHEELCHAIR ACCESSORY
Baseline Model NoJ2 BACK
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilySEATING/POSITIONING SYSTEMS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK901634
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-10-06

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