INSTANT COLD PACK
Received Jun 17, 2003 · Event occurred Apr 30, 2003
Report 1423507-2003-00081 · MDR key 466943
Device
Product problems
- Use of Device Problem
Patient
UNKNOWN
- Bleeding
- Blister(s)
- Fever
- Pain
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
ACCOUNT STATES THAT THE ICE PACK WAS GIVING TO PATIENT FROM DR. OFFICE PATIENT RECEIVED A PAIN INJECTION IN THE BACK. IT IS STATED THAT WHEN PATIENT WOKE UP THE NEXT DAY PATIENT HAD HUGE BLISTERS AND A FEVER. PATIENT WENT TO THE EMERGENCY ROOM AND WAS GIVEN ANTIBIOTICS. THE BLISTERS POPPED THE NEXT DAY AND WERE WORSE, BLEEDING. ON SECOND DAY THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH PAIN AND RECEIVED NO TREATMENT. PATIENT WENT TO THE PHYSICIAN AND HE SAID THAT PATIENT MAY HAVE HAD THE ICE PACK ON THE BACK TOO LONG. PATIENT MISSED WORK FOR 2 WEEKS. WHEN ASKED HOW LONG PATIENT HAD THE ICE PACK ON THE BACK, SPOUSE STATED THAT PATIENT USED IT IN THE EVENING, NOT ALL NIGHT. THE PHYSICIAN TOOK PICTURES OF THE AREA AND PERFORMED TESTS. THE SAMPLE IS AVAILABLE. A KIT NEEDS TO BE SENT TO THEIR HOME FOR RETURNING THE SAMPLE.