Description of Event or Problem · 1
INSULET CORPORATION OMNI-POD PRODUCT CUSTOMER/USER. MFR INSULET CORPORATION MAKER OF OMNI PODS STRONGLY ADVISES TO CHANGE THE OMNI POD AFTER THREE DAYS OF USE. AFTER CHANGING POD ON (B)(6) 2016. I STARTED ITCHING UNDER AND AROUND THE POD, CALLED INSULET CORPORATION CUSTOMER SUPPORT (B)(4) AT 3:11 PM AND SPOKE TO TECHNICAL SUPPORT, (B)(4) AND REPORTED THE ISSUE OF ITCHING PROFUSELY UNDER THE OMNI POD. (B)(4) STATED THE PROBLEM HAD BEEN REPORTED TO THE FDA. I ASKED FOR A SUPERVISOR AND HE SAID THE SUPERVISOR (B)(4) WOULD RETURN MY CALL. CALLED FA ON (B)(6) 2016 AT 10:31 AND SPOKE TO FDA REP. (B)(4), SHE EMAILED ME THE SPECIFIC INSTRUCTIONS ON HOW TO LOOK UP REPORTS AND FIND PROBLEM REPORTED. (B)(4) ALSO STATED INSULTED HAD THE MAXIMUM AROUND OF FILED COMPLAINTS. ON (B)(6) 2016, RECEIVED (B)(4) CALL. (B)(4) STATED THE ADHESIVE SUPPLIER STATED THEY HAVE NOT CHANGED THE PRODUCT. SHE STATED THAT ONE FAMILY HAD A BROTHER AND SISTER ON INSULET CORP. OMNI POD(S) AND ONE REPORTED PROBLEM THE OTHER DID NOT. CLINICAL SPECIALIST SAYS THAT BARD WIPES CREATES A BARRIER TO PREVENT ADHESIVE FROM TOUCHING SKIN AND STATED LOCAL PHARMACIES (B)(6). (B)(6) CARRY THE BARD WIPES. (B)(4) WANTED THE SEQUENCE NUMBER OF THE POD(S) AND SAID SHE WOULD REPLACE PAD PODS (AT THAT TIME I HAD SIX) AND TO RETURN THEM FOR QUALITY PURPOSES. SHE ASKED ME TO KEEP THEM INFORMED AND SAID ANY INSULET CORP REP COULD RECORD NOTES. CALLED INSULET CORP TECHNICAL SUPPORT ON (B)(6) 2016 AT 6:25PM - SPOKE TO (B)(4). TOLD HIM THE ITCHING (ADHESIVE) PROBLEM IS IN ALL THREE BOXES (10 OMNI PODS IN ONE BOX OR A TOTAL OF 30 PODS) WITH SAME LOT #L42472. REF #POD-ZXPP425. CALLED AGAIN ON (B)(6) 2016 AND SPOKE TO TECHNICAL SUPPORT (B)(4) AND ASKED HER TO GET MANAGER, (B)(4) TO CALL ME A. S. A. P. ON (B)(6) 2016 CALLED (B)(6) SHE STATED THEIR SUPPLIER CANNOT GET BARD WIPES, I WOULD HAVE TO GO ONLINE AN ORDER FROM (B)(6). TRIED AGAIN TO REACH MANAGER, (B)(4). PRODUCT SUPPORT (B)(4) WILL SEND HER AN URGENT MESSAGE; HOWEVER, SHE IS IN MEETING. CALLED MY ENDOCRINOLOGIST, DR (B)(6), AND HE SUGGESTED CORTISONE-10 TO RELIEVE ITCHING. IT STOPPED ITCHING BUT OMNI POD WILL NOT ADHERE SO I CAN'T USE IT. ORDERED BARD WIPES BUT THEY WILL NOT ARRIVE UNTIL (B)(6) 2016; (B)(6) 2016 AT 10:04 AM RECEIVED (B)(4) CALL BACK FINALLY! I TOLD HER HOW DISAPPOINTED I AM WITH INSULET CORPORATION AND WILL TAKE PICTURES AND MAY FILE LAW SUIT. INSULET CORPORATION HAS BEEN LACKADAISICAL IN RESOLVING PROBLEM AND I HAVE WHELPS ALL OVER AND CANNOT SLEEP FROM ITCHING. I HOPE TO BE ABLE TO RETURN THE NEW INSULET CORPORATION INSULIN PUMP THAT I HAD TO PURCHASE FROM A THIRD PARTY VENDOR. DIABETES MANAGEMENT AND SUPPLIES, AND GET A REFUND FOR ALL THREE BOXES OF UNUSED OMNI PODS FROM (B)(6). (B)(4) SAID SHE SENT ME SIX REPLACEMENT PODS ON (B)(6) 2016 VIA FED EX AND I SHOULD GET THEM BY (B)(6) 2016. I ASKED HER WHY IT WAS TAKING SO LONG AND SHE MAILED THE VIA FED EX GROUND. SHE SAID CALL WAS BEING RECORDED AND SHE NEEDED ME TO GO THRU HIPPA VERIFICATION AND STATED SHE WOULD TURN THIS OVER TO INSULET CORPORATE SO THEY CAN UNDERSTAND HOW THIS HAS AFFECTED ME. (B)(4) ASKED WHAT IS THE BEST TIME TO CALL AND I SAID AFTER 10:30 AM. (B)(4) SAID INSULET CORPORATE WILL GET BACK TO ME WITHIN 24 TO 48 HOURS. TODAY IS (B)(6) 2016.