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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULED ADULT RECHARGEABLE BATTERY BATTERY, RECHARGEABLE

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TELEFLEX MEDICAL RUSCH TRULED ADULT RECHARGEABLE BATTERY BATTERY, RECHARGEABLE Back to Search Results
Catalog Number 0055502
Device Problem Battery Problem (2885)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 08/05/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product usage when the alleged issue was detected is unknown. The results of the investigation are incomplete at the time of this report.
 
Event Description
The customer alleges that the battery is either broken or has failed. No patient injury reported.
 
Manufacturer Narrative
(b)(4). The sample was not returned for evaluation; therefore, the complaint could not be confirmed. If the sample is returned, a follow-up report will be submitted with investigation results.
 
Event Description
The customer alleges that the battery is either broken or has failed. No patient injury reported.
 
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Brand NameRUSCH TRULED ADULT RECHARGEABLE BATTERY
Type of DeviceBATTERY, RECHARGEABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key5893823
MDR Text Key52668488
Report Number3011137372-2016-00247
Device Sequence Number1
Product Code FCO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0055502
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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