INSTANT COLD THERAPY WRAP
Received Jul 7, 2016 · Event occurred Nov 15, 2015
Report 3005182235-2016-00011 · MDR key 5776000
Device
Generic name
Instant Cold Therapy Wrap
Manufacturer
Tops Medical Articles IndustriesModel number
TMF0362277Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Bruise/Contusion
- Pain
- Swelling
- Bruise/Contusion
- Pain
- Swelling
Narrative
Description of Event or Problem
THE INSTANT COLD THERAPY WRAP WAS WRAPPED AROUND THE USER'S LEFT KNEE. THE USER LEFT THE WRAP ON FOR A HALF HOUR. WHEN SHE TOOK IT OFF, IT WAS STINGING LIKE CRAZY, AND THEN TURNED BLACK AND BLUE. THE BACK OF HER KNEE STARTED TO SWELL. SHE WAS TREATED WITH ANTIBIOTICS, BENADRYL AND PREDNISONE. SINCE THE DAY OF THE EVENT, SHE WAS OFF A FEW DAYS FROM WORK. THE DOCTOR GAVE HER A LOWER DOSE OF ANTIBIOTICS AND A CREME FOR THE AFFECTED AREA. THE DOCTOR THOUGHT IT SHOULD GO AWAY IN 1-2 WEEKS. THE USER WAS USING THE PRODUCT BECAUSE HER MUSCLE WAS HURTING. SHE HAS USED THE PRODUCT IN THE PAST. HER DAUGHTER RUSHED HER TO THE DOCTOR BECAUSE IT SWELLED UP SO BIG.