InjuryIMD

COLDSPOT

Received Apr 17, 2024 · Event occurred Mar 26, 2024

Report 9021987-2024-00001 · MDR key 19124497

Device

Generic name

Cold Therapy Pack

Manufacturer

Beekley Corporation

Model number

502

Catalog number

502

Product problems

Insufficient Device Problem Information
Insufficient Device Problem Information

Patient

NA · Unknown

Blister
Blister

Narrative

Description of Event or Problem

A PATIENT HAD A BREAST BIOPSY WHERE A COLDSPOT 502 COLD THERAPY PACK WAS USED AFTERWARDS. WHEN THE PATIENT RETURNED FOR THEIR FOLLOW-UP, THE RADIOLOGIST NOTICED THE PATIENT HAD BLISTERS SCARRING AND DISCOLORATION OF THE SKIN IN THE AREA OF THE BIOPSY.