ColdSPOT 502Recalls & reported problems
Beekley Corporation · Cold Therapy Packs, 2.0x3.0" gel pack, with Florals · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815137021084), received between Apr 17, 2024 and Apr 17, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Blister1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
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.
Patient problems: Blister
MAUDE report 19124497 ↗
Other Pack, Hot Or Cold, Disposable devices
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- CARDINAL HEALTH 11443-012BCardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE56 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE37 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Neck, Wrist & ShoulderPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE1 death31 reports
- CARDINAL HEALTH 11450-040Cardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE20 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE14 reports
- Medline MDS139008Medline Industries, Inc. · PACK, HOT OR COLD, DISPOSABLE13 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.