Medline MDS137000Recalls & reported problems
Medline Industries, Inc. · PACK,COLD,INSTANT,STANDARD,5.75"X9" · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00080196732336), received between Mar 1, 2023 and Apr 27, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Leak/Splash1
- Patient Device Interaction Problem1
Patient problems
- Burn(s)2
- Blister1
- Chemical Exposure1
- Chills1
- Nerve Damage1
- Pain1
- Scar Tissue1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2026Leak/Splash
ACCORDING TO THE CUSTOMER VIA PHONE CALL, ON (B)(6), THE USER BUMPED LEFT ARM AND USED THE PACK. THE BURN WAS ON LEFT ARM ABOUT 4 INCHES AND THICK.
Patient problems: Burn(s); Chills
MAUDE report 25008908 ↗InjuryJan 16, 2026Patient Device Interaction Problem
ACCORDING TO THE CUSTOMER, AFTER APPLYING THE ICE PACK FOR "GROIN PAIN" FOR "A LITTLE WHILE" TO THE "LEFT SIDE" OF THE GROIN ON (B)(6) 2025 HE FELT A "BURNING SENSATION", AND THE SKIN "LOOKED LIKE A HUGE BLISTER (BUBBLED UP SKIN)". THE CUSTOMER REPORTED THAT THE FOLLOWING DAY THE "TOP SKIN WAS GONE", AND THERE WAS "RAW FLESH WITH A HOLE".
Patient problems: Blister; Burn(s); Nerve Damage; Pain; Scar Tissue
MAUDE report 24094614 ↗InjuryMar 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 AFTER ACTIVATING THE COLD PACK "ACCORDING TO INSTRUCTIONS ON THE PACK," THE COLD PACK WAS PLACE ON THE PATIENT'S RIGHT SIDE OF HER NOSE WHEN THE PACK LEAKED, AND WENT INTO THE PATIENT'S MOUTH.
Patient problems: Chemical Exposure
MAUDE report 16462590 ↗
Other PACK, HOT OR COLD, DISPOSABLE devices
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE196 reports
- NOVAPLUS V11460-010Cardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE1 recall16 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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