Defender, Pair 08-0028Recalls & reported problems
Precision Medical Products, Inc. · Class 2
- 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 00194832000052), received between Mar 5, 2026 and Mar 5, 2026 — 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
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2026Insufficient Device Problem Information
PATIENT WAS WEARING DEVICE ON CALF OF LEFT LEG. STAFF NOTED PATIENT HAD A DEGREE OF LACK OF SENSITIVITY ON LEFT LEG AND PATIENT IS POSITIVE FOR MRSA. VA NURSING STAFF WAS REVIEWING THE PATIENT'S SKIN AND IDENTIFIED SKIN INJURY, THEN THEY CONTACTED WOUND NURSE, WHO CONSULTED FOR WOUND ORDER. THE WOUND RN COULDN'T FOR SURE DETERMINE IF IT WAS A WOUND, BURN OR MED DEVICE RELATED INJURY, BUT WHERE THE "WOUND" WAS IS RIGHT UNDER WHERE THE BATTERY PACK WAS RESTING. STAFF TOOK OFF DEFENDERS AND LEFT THEM OFF. AND HAVE DISCONTINUED USE FOR THE WHOLE FLOOR FOR THE TIME BEING. PATIENT WAS FORWARDED TO THE WOUND TEAM AND DEVELOPED A PLAN OF CARE. RECOVERY AND STATUS UPDATE OF THE PATIENT'S SKIN CONDITION IS STILL UNKNOWN.
Patient problems: Tissue Breakdown
MAUDE report 24518509 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.