Description of Event or Problem · 1
I RECEIVED FROM LINCARE A DEFECTIVE CHIN STRAP FOR CONTROLLING SLEEP APNEA. I BELIEVE LINCARE MAY HAVE SUBSTITUTED A NON-APPROVED PRODUCT FOR THE APPROVED RESPIRONICS PREMIUM CHIN STRAP THAT WAS PRESCRIBED FOR ME BY MY PULMONOLOGIST. THE NEW PRODUCT DID NOT WORK EFFECTIVELY BECAUSE I COULD NOT KEEP IT TIGHT ENOUGH, AND THE FABRIC DELAMINATED IN LESS THAN 2 WEEKS. I NOTICED THAT THE LABEL ON THE REPLACEMENT PRODUCT BAG SAID IT WAS AN APPROVED REPLACEMENT FOR THE RESPIRONICS PRODUCT. UNFORTUNATELY, I DID NOT SAVE THE LABEL. WHEN I REPORTED THE PROBLEM TO LINCARE, THE CUSTOMER SERVICE AGENT SAID THIS WAS THE ONLY PREMIUM CHIN STRAP LINCARE CARRIED AND I SHOULD TRY ANOTHER MODEL. I ORDERED ANOTHER MODEL BUT DID NOT RECEIVE IT. ALTHOUGH I WAS NOT NOTIFIED BY LINCARE IN ANY WAY, WHEN I FOLLOWED UP TO CHECK ON SHIPMENT OF THE NEW MODEL. I WAS TOLD THEY COULD NOT SEND THE OTHER MODEL BECAUSE IT WAS NOT WHAT WAS PRESCRIBED. I ASKED FOR A RESPIRATORY THERAPIST TO FIT ME FOR ANOTHER MODEL AND WAS TOLD LINCARE RESPIRATORY THERAPISTS DID NOT PROVIDE THIS SERVICE. IN DESPERATION, I ORDERED, AT MY OWN EXPENSE, THE RESPIRONICS PREMIUM CHIN STRAP FROM ANOTHER SUPPLIER, WHICH I HAVE RECEIVED, AND WHICH WORKS AS EXPECTED. UPON VISUAL COMPARISONS, IT IS IMMEDIATELY OBVIOUS THAT THE PRODUCT WHICH LINCARE PROVIDED IS NOT COMPARABLE IN MATERIAL OR CONSTRUCTION TO THE RESPIRONICS PRODUCT. I STILL HAVE THE DEFECTIVE PRODUCT AS WELL AS MY WORN ORIGINAL CHIN STRAP FROM LINCARE WHICH WORKED WELL FOR A LONG TIME, PERHAPS A YEAR OR MORE, BUT I NO LONGER HAVE THE BAG AND LABEL FOR EITHER ONE. MY ORIGINAL CHIN STRAP IS SIMILAR IN MATERIAL BUT VERY DIFFERENT IN CONSTRUCTION COMPARED TO THE NEW LINCARE PRODUCT. FDA SAFETY REPORT ID # (B)(4).