ERGOLINE 34/3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-30 for ERGOLINE 34/3 manufactured by Jk Products & Services.

Event Text Entries

[14874406] Customer rolled out of the tanning bed and broke the base acrylic injuring their shoulder.
Patient Sequence No: 1, Text Type: D, B5


[15338491] The user exceeded the weight capacity of the device. The acrylic exceeded it's life expectancy.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2311923-2014-00006
MDR Report Key4003508
Report Source06
Date Received2014-07-30
Date of Report2014-07-28
Date of Event2014-05-01
Date Mfgr Received2014-07-23
Device Manufacturer Date2012-07-01
Date Added to Maude2014-08-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLATEEF KHAN
Manufacturer Street1 WALTER KRATZ DR.
Manufacturer CityJONESBORO AR 72401
Manufacturer CountryUS
Manufacturer Postal72401
Manufacturer Phone8709351130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameERGOLINE
Generic NamePASSION
Product CodeLEJ
Date Received2014-07-30
Model Number34/3
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerJK PRODUCTS & SERVICES
Manufacturer AddressJONESBORO AR US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-07-30

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