ERGOLINE 1100

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 2013-04-08 for ERGOLINE 1100 manufactured by Jk Products Gmbh.

Event Text Entries

[3391733] Claimant alleges bed caught fire.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615023-2013-00001
MDR Report Key3057351
Report Source06
Date Received2013-04-08
Date of Report2013-04-01
Date of Event2013-03-31
Date Mfgr Received2013-04-01
Date Added to Maude2013-04-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLATEEF KHAN
Manufacturer StreetRITTBITZER STRASSE 69
Manufacturer CityBAD HONNEF 53604
Manufacturer CountryGM
Manufacturer Postal53604
Manufacturer Phone9351130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameERGOLINE
Generic NamePRESTIGE 1100
Product CodeLEJ
Date Received2013-04-08
Model Number1100
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerJK PRODUCTS GMBH
Manufacturer AddressBAD HONNEF 53604 GM 53604


Patients

Patient NumberTreatmentOutcomeDate
10 2013-04-08

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