PIEZOWAVE2
Received Jul 8, 2025 · Event occurred Jun 7, 2023
Report 9611102-2025-00031 · MDR key 22442734
Device
Generic name
Piezowave 2 Control Unit
Manufacturer
Richard Wolf GmbhModel number
100505Catalog number
100505
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Stroke/CVA
- Stroke/CVA
Narrative
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.
Description of Event or Problem
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.