MAUDE MDR 748635

MDR report key
748635
Report number
MW1037087
Event key
0
Event type
3
Date of event
2005-09-26
Date received
2005-11-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SCREW AND LOC VIAL SYSTEMPRESCRIPTION VIALOWENS ILLINOISNXB***NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-11-0201. O

Event Narratives#

D

Patient 1

RPTR'S SON INGESTED MY HUSBAND'S CHOLESTEROL MEDICATION AND RPTR'S THYROID MEDICATION. IN A HORRIFIC PANIC RPTR CONTACTED POISON CONTROL IMMEDIATELY AND THEY STATED BASED UPON THE NUMBER OF PILLS CONSUMED HE SHOULD BE FINE AND VOMIT WHICH HE DID LATER IN THE DAY. AFTER ASKING THEM IF RPTR SHOULD TAKE HIM TO THE PHYSICIAN THEY AGREED THAT PERHAPS THEY SHOULD. AFTER RPTR'S NERVES CALMED RPTR WONDERED HOW A THREE YR OLD CHILD WAS ABLE TO OPEN A CHILD RESISTANT "SCREW AN LOC VIAL SYSTEM." RPTR EXAMINED THE BOTTLES AND TO THEIR DISBELIEF WAS ABLE TO OPEN IT WITHOUT HAVING TO APPLY PRESSURE ON THE LID AND TURN. ONLY TURNING THE LID IT OPENED THEN THEY TOOK THE BOTTLES TO THE PHARMACY WHERE THEY WERE PURCHASED AND SHOWED THEM HOW THEY FAILED TO PERFORM AS THEY WERE SUPPOSED TO. THE PHARMACIST HAS RPTR'S TWO NEW BOTTLES WHICH OPENED IN THE SAME MANNER. WHEN RPTR ARRIVED HOME THEY CONTACTED THE STORE'S CONSUMER AFFAIRS DEPARTMENT TO ALSO REPORT THE PROBLEM. AFTER A WEEK OF CONVERSATIONS WITH THE STORE RPTR WAS GIVEN THE MANUFACTURER WHOM IS OWNE ILLINOIS. RPTR NOTIFIED QUALITY CONTROL.