DeRoyal T700Recalls & reported problems
Deroyal Industries, Inc. · JetStream Hot/Cold Therapy Unit · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756868235), received between Oct 15, 2018 and Oct 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2018Fracture; Fracture
QUALITY ISSUE DETAILS- DATE OF OCCURRENCE: (B)(6) 2018. WHEN DID QUALITY ISSUE OCCUR? DURING USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? PATIENT/END CONSUMER. WAS A MEDICAL PROCEDURE INVOLVED? YES. NAME OF MEDICAL PROCEDURE: RIGHT TOTAL KNEE REPLACEMENT. DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NO (PLEASE PROVIDE LENGTH OF DELAY AND ANY OTHER DETAILS ABOUT THE PROCEDURE IN THE DETAILED DESCRIPTION FIELD BELOW). DETAILED DESCRIPTION OF QUALITY ISSUE: DEVICE IS LEAKING AT THE CONNECTING HOSE. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? THERAPY. WAS IT THE INITIAL USE OF THE PRODUCT? YES. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? NO. OUTCOME DETAILS- OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED. WAS THE INCIDENT REPORTED TO THE FDA? YES - REPORTED ON (B)(6) 2018. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY AD
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7964834 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.