EXOGEN 4000 SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-28 for EXOGEN 4000 SYSTEM manufactured by Bioventus.

Event Text Entries

[4620853] Fda: the exogen bone healing device was approved by the fda. The company advertise as it having no side effects. In my case (and probably others), this was not true. When speaking with someone in their headquarters - the one question she asked was "how much metal do you have in you" - (i have a quite a bit). I think there should be a warning for people like me since this is a very expensive piece of equipment. No way would i have invested had this warning been posted. Bioventures: to say the exogen device has no side effects is certainly not true. I experienced the same side effects with the replacement as i did with the original. One must take in the facts of chemistry, nervous system and above all, i believe - the amount of hard-ware in the break. In my case, i have a large bolt-facer screws and a rod up the femur. I desperately wanted to use the device and i tried everything! Less timing - various times of day, etc. No matter what i tried and i got the same results. Lots of pain and a burning in my whole leg. Since not using it, i have not experienced any of the pain. You should warn before you sell such an expensive device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5036389
MDR Report Key3845824
Date Received2014-05-28
Date of Report2014-05-01
Date of Event2014-01-01
Date Added to Maude2014-06-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEXOGEN 4000 SYSTEM
Generic NameEXOGEN 4000 SYSTEM
Product CodeLPQ
Date Received2014-05-28
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0
ManufacturerBIOVENTUS


Patients

Patient NumberTreatmentOutcomeDate
10 2014-05-28

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