InjuryPZL
SOFTWAVE (name which patient reported) - correct: SOFTWAVE GOLD-LI
Received Jul 30, 2026 · Event occurred Feb 4, 2026
Report 3005462245-2026-00001 · MDR key 50084120
Device
Generic name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcer
Manufacturer
Mts Medical AgModel number
OW100S-USCatalog number
1000021
Lot number
Produktion date: 10/25/2024
Product problems
- Inappropriate/Inadequate Shock/Stimulation
- Patient Device Interaction Problem
Patient
51 YR · Female
- Undesired Nerve Stimulation
- Neuropathy
- Pain
- Burning Sensation
- Ambulation or Postural Difficulties
- Pelvic Pain