DPX X-RAY BONE DENSITOMETER NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-03 for DPX X-RAY BONE DENSITOMETER NI manufactured by Lunar Corp.

Event Text Entries

[189993] Rptr is writing in regards to a letter of warning that was sent to president of the lunar corp. On 8/5/93, concerning investigation of their dpx x-ray bone densitometer. This "warning of letter" seemed to be mostly concerned with the technical compliances of their device. Rptr is in hopes that center of devices and radiological health would have also investigated clinical records concerning the safety of this device. The reason for rptr's interest in this matter is because they have experienced a negative reaction from this device's testing and if rptr could be negatively affected by it, then there must be others who have had problems with it too. Rptr would appreciate greatly any info in this direction this agency can give them. In 1999 at 4 pm rptr had a bone densimeter dpx x-ray test done for the diagnosis of osteoporosis. That same night rptr was awakened with excruciatingly sharp pains along the entire left leg. (this was the leg that was tested). The leg also seemed to be extremely heavier than the right leg when rptr tried to raise it while lying in bed. Then, when rptr got out of bed, it was tremendously painful to put their weight on this left leg to try to walk. When rptr was having the test done, the tech had to start the device twice. Tech said it had given her trouble all day. When it finally started, she left the room. When it was directed down rptr's left hip to ankle. Rptr felt a tringly, prickly, slightly warming sensation several times as it progressed down hip and leg. The very same places rptr felt this sensation as rptr was being tested, was the very same places the pain was originating from. It is going on eight months now and rptr has several indentations along the outside of this left leg that pulls in when rptr walks on it. Rptr also cannot extend their leg to walk at a normal gait because of this pulling - like the fusion of tissue. The pain has very slowly gotten less, but has never diminished. Rptr has also been unable to draw their body weight up on stepls without a log of pulling and pain in this left leg. Rptr has also developed a stomach problem from the extended use of nioxx. 25 mg that was prescbribed for this injury. This medicine relieved the pain some but did not alleviate it. Rptr is in hopes agency can provide them with some records of others who have been affected negatively by this device. Rptr cannot believe they are the only one that has experienced a problem after being tested by this device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1021683
MDR Report Key328751
Date Received2001-04-03
Date of Report2000-06-21
Date of Event1999-11-02
Date Added to Maude2001-04-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDPX X-RAY BONE DENSITOMETER
Generic NameDENSITOMETER
Product CodeKGI
Date Received2001-04-03
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
Device AvailabilityN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key318123
ManufacturerLUNAR CORP
Manufacturer Address313 WEST BELTLINE HWY MADISON WI 53713 US


Patients

Patient NumberTreatmentOutcomeDate
10 2001-04-03

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