SHOCKWAVE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-14 for SHOCKWAVE manufactured by Unk.

Event Text Entries

[62860810] Date is approximate. Shockwave treatment caused me to miscarry a pregnancy. I was treating for work comp injuries with (b)(6), dc at (b)(6) clinic. The clinic has since been closed as a part of a suspected work comp fraud ring. My complaint is about his improper use of shockwave electrotherapy. The treatment was applied to my shoulder. I was told it would help me heal from my injuries. Pain was debilitating and i was desperate. No other treatment modalities had been attempted as described in the information which the fda has online. I only recently found this information about this treatment. I was not aware i was pregnant. I had just been to a fertility doctor with my husband and told that doctor i was late and that we might not need his services. The fertility doctor did not offer a pregnancy test which my insurance would have covered. The fertility doctor did not advise me to be careful. So when this shockwave treatment was offered, i felt obliged to accept it. Dr. (b)(6) did not offer a pregnancy test. Dr. (b)(6) did not ask me if i thought i could possibly be pregnant or if i was even late getting my period. Dr. (b)(6) did not ever offer any other treatment modalities except tens and chiropractic manipulation. No other doctor at (b)(6) clinic offered any other treatment modalities prior to that date. I am very upset over this to this day because my husband and i were trying to have children and that was my only chance. We had been tying for some time without any success. I did not even know i was pregnant until the very small fetus expelled.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5066793
MDR Report Key6186423
Date Received2016-12-14
Date of Report2016-12-14
Date of Event2014-02-24
Date Added to Maude2016-12-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSHOCKWAVE
Generic NameSHOCKWAVE
Product CodeNCV
Date Received2016-12-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-12-14

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