BLDG Active 1406Recalls & reported problems
Innovacyn, Inc. · Class U
Data updated Oct 16, 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 00818582012560), received between Jun 4, 2025 and Jun 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
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.
InjuryJun 4, 2025Biocompatibility; Biocompatibility
IN REVIEWING THE AMAZON CUSTOMER REVIEWS ON (B)(6) 2025, CUSTOMER SERVICE TEAM MEMBER IDENTIFIED A SAFETY CONCERN. IT WAS FOUND THAT CUSTOMER, (PARENT OF (B)(6) HAD POSTED THE FOLLOWING REVIEW ON (B)(6) 2025: "MY DAUGHTER HAD A SEVERE DIAPER RASH SO I LOOKED UP WHAT WOULD BE THE BEST CREAM SPRAY OR ANYTHING FOR HER THIS CAME HIGHLY RATED SO I HAD IT OVERNIGHTED AND STARTED TO USE IMMEDIATELY I SHOULD HAVE DONE A SMALL TEST AREA SOMEWHERE ELSE ON HER SKIN MY DAUGHTER ENDED UP WITH A COMPLETE ALLERGIC REACTION AND IN THE HOSPITAL FOR 3 DAYS WITH THE DOCTORS VERIFYING THIS SPRAY WAS THE CAUSE IT WAS VERY SCARY FOR MY NEWBORN AND ME PLEASE TEST ON A SAFE AREA ON YOUR CHILD AND THERE IS NO GUARANTEE OR REFUND AVAILABLE FOR THIS PRODUCT I TRIED TO POST A PICTURE BUT MY REVIEW WAS DENIED WITH THE PHOTO REACTION AND PROOF FROM THE DOCTOR." THROUGH FOLLOW UP EXCHANGE ADDITIONAL INFORMATION WAS OBTAINED AS FOLLOWS: CUSTOMER PURCHASED PRODUCT TO TREAT DIAPER RASH OF HIS/HER INFANT. CUSTOMER OBSERVED FULL BODY RASH WITHIN 15 MIN OF PRODUCT USE. IT IS UNCLEAR WHETHER THE INFANT WAS BROUGHT TO HOSPITAL FOR DIAPER RASH OR PRODUCT REACTION. DURING THE HOSPITAL STAY, THE ATTENDING PHYSICIAN REPORTE
Patient problems: Rash
MAUDE report 22145983 ↗
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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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