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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMWAVE WAA WEARABLE ANTENNA ASSEMBLY

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STIMWAVE TECHNOLOGIES INC. STIMWAVE WAA WEARABLE ANTENNA ASSEMBLY Back to Search Results
Model Number PDBT-915-2K
Device Problem Unintended Electrical Shock (4018)
Patient Problem Electric Shock (2554)
Event Date 04/06/2021
Event Type  Injury  
Manufacturer Narrative

Stimwave initiated (b)(4) to return the device for investigation. The device history record was reviewed, and no non-conformances or issues which could have led to the failure of the device were identified. On may 4, 2021, stimwave investigated the device for the alleged shock. The device was verified on an engineering bench and tested in the factory waa test. Investigation of the device was unable to replicate the alleged issue, and no non-conformances were found. There is no root cause, as no problem was found.

 
Event Description

On april 21, 2021, stimwave received a complaint in which the patient had reported to the clinical representative experiencing a shock while using specific program settings.

 
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Brand NameSTIMWAVE WAA
Type of DeviceWEARABLE ANTENNA ASSEMBLY
Manufacturer (Section D)
STIMWAVE TECHNOLOGIES INC.
1310 park central boulevard s.
pompano beach FL 33064
Manufacturer (Section G)
STIMWAVE TECHNOLOGIES INC.
1310 park central boulevard s.
pompano beach FL 33064
Manufacturer Contact
andrea najera
1310 park central boulevard s.
pompano beach, FL 33064
8009655134
MDR Report Key11784725
MDR Text Key249289695
Report Number3010676138-2021-00086
Device Sequence Number1
Product Code GZF
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK171366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 05/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberPDBT-915-2K
Device LOT Number00383-S
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/06/2021 Patient Sequence Number: 1
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