inforMED
InjuryFMW

PROTECT-A-BED = ALLERZIP

Received Apr 5, 2011 · Event occurred Apr 5, 2011

Report MW5020173 · MDR key 2048216

Device

Generic name

Allerzip

Manufacturer

Protect-a-bed

Lot number

234532

Product problems

  • Material Integrity Problem

Patient

54 YR

  • Rash

Narrative

Description of Event or Problem

THIS COMPANY HAS BEEN USING THE FDA NAME ALL OVER THEIR PRODUCTS AND DECEIVING US CUSTOMERS INTO THINKING THAT THEY HAVE FDA APPROVAL. THEY DO NOT. IN (B)(6) THEY DID THE SAME THING AND HEALTH (B)(6) FORCED THEM TO TAKE THE NAME "HEALTH (B)(6)" OFF ALL THEIR MARKETING MATERIAL. A COMPANY SHOULD NOT HAVE THE RIGHT TO USE THE FDA NAME ALL OVER THEIR PRODUCTS JUST TO SELL IT AND CONFUSE THE CONSUMER INTO BELIEVING THAT IT IS APPROVED BY THE FDA. THIS IS NOT RIGHT AND SHOULD NOT CONTINUE. IF (B)(6) WAS ABLE TO OPEN THEIR EYES TO THIS WHY CAN'T THE FDA? NOW HERE IS WHAT HAPPENED TO ME. I BOUGHT A PROTECT-A-BED PRODUCT BECAUSE I READ THAT IT WAS APPROVED BY THE FDA. WHEN IT GOT HOME WITH IT I WASHED IT AND THEN PUT IT ONTO MY BED. THIS DESTROYED THE PRODUCTS FOAM PROTECTION AROUND THE ZIPPER AND AFTER A NIGHT OF SLEEPING I WAS COMPLETELY BITTEN BY BED BUGS. I HAD TO GO TO THE HOSPITAL FOR A VACCINE TO HELP WITH ALL MY RASHES. I HAVE DOCTOR REPORTS. (B)(6).