MAUDE Adverse Event Report: MTS MEDICAL UG ORTHOGOLD100, MODEL OW100-US

Model Number OW100-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tinnitus (2103); Increased Sensitivity (4538)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

Following information received from provider / user: name of clinic: (b)(6).Address: (b)(6).Contact: (b)(6).Technician: (b)(6).Doctor who performed first consultation: dr.(b)(6).Also known as dr.(b)(6).Patient (b)(6) first met with dr.(b)(6) on (b)(6) 2023 to develop a treatment plan.(b)(6) 2023 was also the first day of treatment which was performed by (b)(6).After the first treatment 2 more were performed on (b)(6).Patient wanted back-to-back treatments due to limited availability.Patient was not offered ear protection at any of the treatments.On (b)(6) 2023 the patient made a complaint regarding ringing in the ear which at that time softwave treatment ended and she proceeded to received fx laser treatment.It is to note that during the first consultation the patient did admit to having swam a few weeks before treatment and had to visit urgent care immediately after for ear trouble.Device s/n: (b)(6).Applicator s/n: (b)(6).No.Of shockwaves for each treatment: 500.Energy level for each treatment: 11-12.Training protocol of the user: standard softwave trt training.Did the patient wear ear protection: no.Was medical or surgical intervention necessary: no.Assessment by manufacturer: manufacturer considers incident not serious according risk management plan and risk analysis of the device.According to the risk analysis the incident is considered severity level minor.Mitigations according risk analysis: (1) the instruction for use (ifu) contains a warning to wear ear protection: warning: noise protection measures! the release of shock waves produces noise.To protect patients and medical personnel, take appropriate noise protection measures, e.G.By providing ear protectors.(2) a label to wear ear protection is fixed on outside of the device.(3) also the user receives a training prior to use.This medwatch 3500a is being submitted in response to the information reported in mdr report #: mw5151136 by patient.And in response to fda request.

Event Description

Patient filed a medwatch 3500 form with the following descriptiopn: mw5151136.Softwavetrt: signed up for a consultation/sample for softwavetrt treatment on my back/shoulder blade are and was offered a package for multiple treatments.The technician did a little on my shoulder blade but focused on my shoulder and left trapezius.My 2nd treatment on (b)(6) 2023 resulted in a vibration in my ears that went away after a day.My 3rd treatment left me with ringing in both ears, more on the left.The technician said the ringing could not be caused by the softwave, but after a 4th treatment, i had ringing, pressure, and pain in my ears.I still have the ringing in both ears and increased volume as of (b)(6) 2024.I also have times of noise sensitivity.

• Brand Name: ORTHOGOLD100, MODEL OW100-US
• Type of Device: OW100-US
• Manufacturer (Section D): MTS MEDICAL UG; robert-bosch-str. 18; konstanz, germany 78467 ; GM 78467
• Manufacturer (Section G): MTS MEDICAL UG; robert-bosch-str. 18; konstanz, germany 78467 ; GM 78467
• Manufacturer Contact: ralph reitmajer ; robert-bosch-str. 18; konstanz, germany 78467 ; GM 78467
• MDR Report Key: 18789815
• MDR Text Key: 336349497
• Report Number: 3005462245-2024-00001
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 210451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OW100-US
• Device Catalogue Number: 1000013
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female