DONJOY 11-1334-9-00000Recalls & reported problems
Djo, LLC · COLD PAD, SHOULDER, LOOP, NS · Class 2
All models of DONJOY (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00888912005654), received between Jan 19, 2017 and Jan 19, 2017 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT RECEIVED THAT ALLEGES "DEVELOPED A RASH ON HER ARM FROM WETNESS SHE FELT COMING FROM THE PAD. EXPERIENCED ITCHING REDNESS AND DISCOLORIZATION ON HER SKIN. SHE SAYS THAT SHE HAD A TOWEL BETWEEN THE PAD AND SKIN. WENT TO ER RECEIVED BENADRIL AND ANTI-BIOTICS". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.
Patient problems: Rash
MAUDE report 6264316 ↗
Other Pack, hot or cold, water circulating devices
- DONJOY 11-0494Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-1422Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-9099Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- Electri-Cool ll 767Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- Micro-Temp LT 749Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- DONJOY 11-1424Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- T/Pump TP700Stryker Corporation · Pack, hot or cold, water circulating15 reports
- Mul-T-Pad 8002-062-026Stryker Corporation · Pack, hot or cold, water circulating7 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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