RUSCH TRULED ADULT RECHARGEABLE BATTERY 0055502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-05-02 for RUSCH TRULED ADULT RECHARGEABLE BATTERY 0055502 manufactured by Teleflex Medical.

Event Text Entries

[44136393] (b)(4). Conclusion - a conclusion code could not be chosen. The complaint was confirmed, but the root cause is unknown. Upon receipt the rechargeable led cartridge was visually examined for any signs of damage, misuse/abuse and no issues were noted. An attempt was made to charge the cartridge with the charging unit that is shipped in the kit with the handle and led cartridge. The red glowing charging light would not energize. The cartridge was destructively inspected. Visual signs of corrosion beginning were found on top of the lithium-ion battery and the small led electronic driving module. The complaint has been confirmed. The lithium-ion battery leaked causing destructive corrosion inside the led cartridge housing that prevented the battery from charging. The complaint has been confirmed. Root cause cannot be established with the current information provided. No corrective/preventative actions will be assigned. Corroding batteries could be the result of age, extreme heat and/or cold, contact with other corrosive materials. However, these are just suggested root causes and cannot be assigned to this complaint.
Patient Sequence No: 1, Text Type: N, H10


[44136394] The customer alleges that the device failed. Battery failing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011137372-2016-00086
MDR Report Key5623676
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2016-05-02
Date of Report2016-04-11
Date of Event2016-04-11
Date Mfgr Received2016-04-11
Date Added to Maude2016-05-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMARGIE BURTON, RN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal Code27560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH TRULED ADULT RECHARGEABLE BATTERY
Generic NameBATTERY, RECHARGEABLE
Product CodeFCO
Date Received2016-05-02
Returned To Mfg2016-04-20
Catalog Number0055502
Lot NumberUNKNOWN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2016-05-02

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