MAUDE Adverse Event Report: MTS MEDICAL UG ORTHOGOLD100; MASSAGER, THERAPEUTIC, ELECTRIC

Model Number OW100-US

Device Problem Insufficient Information (3190)

Patient Problem Numbness (2415)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer considers incident not serious according adverse events listed in ifu of the suspected device orthogold100 and the risk management plan of the manufacturer.This medwatch 3500a is being submitted in response to the information reported in mw5107111.

Event Description

Incident was already reported to fda under mdr report #mw5107111.

• Brand Name: ORTHOGOLD100
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): MTS MEDICAL UG; robert-bosch-str. 18; konstanz DE 78467
• Manufacturer (Section G): MTS MEDICAL UG; robert-bosch-str. 18; konstanz, de 78467 ; GM 78467
• Manufacturer Contact: ralph reitmajer ; robert-bosch-str. 18; konstanz, de 78467 ; GM 78467
• MDR Report Key: 14367384
• MDR Text Key: 291492721
• Report Number: 3005462245-2022-00001
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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