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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a piezowave 2 was used on a patient for myofascial acoustic compression therapy (myact) on the left leg in a medical facility.The patient was subsequently diagnosed with an acute meniscus root tear in her left knee, confirmed by imaging, as well as persistent neuropathic symptoms; however, based on the current clinical assessment and available findings, a direct causal link to the myact treatment is considered unlikely and cannot be confirmed.

• 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: 23633150
• Report Number: 9611102-2025-00059
• Device Sequence Number: 15786947
• Product Code: ISA
• UDI-Device Identifier: 04055207008454
• UDI-Public: 04055207008454
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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: Other
• Device Model Number: 100505
• Device Catalogue Number: 100505
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown