InjuryISA
ORTHOGOLD100
Received May 12, 2022 · Event occurred Jan 24, 2022
Report 3005462245-2022-00001 · MDR key 14367384
Device
Generic name
Massager, Therapeutic, Electric
Manufacturer
Mts Medical UgModel number
OW100-USCatalog number
1000013
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Unknown
- Numbness
- Numbness
Narrative
Additional 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.
Description of Event or Problem
INCIDENT WAS ALREADY REPORTED TO FDA UNDER MDR REPORT #MW5107111.