MAUDE Adverse Event Report: STORZ MEDICAL AG D-ACTOR; THERAPEUTIC MASSAGER

Device Problem Use of Device Problem (1670)

Patient Problems Hearing Impairment (1881); Tinnitus (2103)

Event Date 02/19/2024

Event Type  Injury  

Event Description

Patient complaint of sudden hearing lass and loud tinnitus as soon as it contacted the mastoid/occipital bone after radial shockwave therapy.Patient reports to not wearing ear portection during treatment.

Manufacturer Narrative

The energy/transmitter used are apparently flne.A possible issue is that the transmitter has been in direct contact to the mastoid/occipital bone.In the instructions for use we warn agalnst the application of pulses to any regions near the head.Even though the noise level of pulses is within the safe range, we recommend wearing suitable ear protection during treatment in order to minimise exposure to noise.

• Brand Name: D-ACTOR
• Type of Device: THERAPEUTIC MASSAGER
• Manufacturer (Section D): STORZ MEDICAL AG; lohstampfestrasse 8; taegerwilen, thurgau 8274 ; SZ 8274
• Manufacturer (Section G): STORZ MEDICAL AG; lohstampfestrasse 8; tägerwilen, thurgau ; SZ
• Manufacturer Contact: devonne pavlak ; 1000 cobb place blvd.; building 400 suite 450; kennesaw, GA
• MDR Report Key: 19037870
• MDR Text Key: 339303596
• Report Number: 3002808188-2024-00001
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 03/03/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female