MAUDE Adverse Event Report: RICHARD WOLF GMBH PIEZOWAVE2; PIEZOWAVE 2 CONTROL UNIT

Model Number	100505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the batch records for the control units and therapy sources sold to the chiropractor was conducted confirming that the devices met all specifications and no production issues were identified.There are no other complaints of this nature identified from a richard wolf complaint database search.This mdr is submitted in an abundance of caution.
Event or Problem Description
Richard wolf was informed that a patient experienced a stroke after manual chiropractic manipulation.Prior to the manual chiropractic treatment, the piezowave was used for myofascial acoustic compression massage.There is no information available from the chiropractor on the specific piezowave control unit or therapy source that were utilized during the treatment.The chiropractor continues to use the piezowave units and therapy sources for myofascial acoustic compression massage treatment.

• Brand Name: PIEZOWAVE2
• Common Device Name: PIEZOWAVE 2 CONTROL UNIT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22442734
• Report Number: 9611102-2025-00031
• Device Sequence Number: 7904570
• Product Code: ISA
• UDI-Device Identifier: 04055207008454
• UDI-Public: 04055207008454
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100505
• Device Catalogue Number: 100505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Female