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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 SP STEPPING HEAD BRACHYTHERAPY EQUIPMENT & ACCESSORIES

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BARD BRACHYTHERAPY, INC. -1424526 SP STEPPING HEAD BRACHYTHERAPY EQUIPMENT & ACCESSORIES Back to Search Results
Model Number D01000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2020
Event Type  malfunction  
Manufacturer Narrative
As the serial number for the device was provided, a review of the device history records is currently being performed. The return of the device is pending. The investigation of the reported event is currently underway.
 
Event Description
It was reported that during a procedure, the in-out wheel allegedly slipped when locked. There was no reported patient injury.
 
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Brand NameSP STEPPING HEAD
Type of DeviceBRACHYTHERAPY EQUIPMENT & ACCESSORIES
Manufacturer (Section D)
BARD BRACHYTHERAPY, INC. -1424526
295 east lies road
carol stream 60188
Manufacturer (Section G)
BARD BRACHYTHERAPY, INC. -1424526
295 east lies road
carol stream 60188
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11045086
MDR Text Key222649934
Report Number2020394-2020-20892
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD01000
Device Catalogue NumberD01000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/21/2020 Patient Sequence Number: 1
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