MAUDE Adverse Event Report: SHOCKWAVE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Miscarriage (1962)

Event Date 02/24/2014

Event Type  Injury  

Event Description

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.

• Brand Name: SHOCKWAVE
• Type of Device: SHOCKWAVE
• MDR Report Key: 6186423
• MDR Text Key: 62860810
• Report Number: MW5066793
• Device Sequence Number: 1
• Product Code: NCV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RX MEDS: ARMOUR THYROID
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 101