SCREW AND LOC VIAL SYSTEM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-02 for SCREW AND LOC VIAL SYSTEM * manufactured by Owens Illinois.

Event Text Entries

[20992469] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1037087
• MDR Report Key: 748635
• Date Received: 2005-11-02
• Date of Report: 2005-11-02
• Date of Event: 2005-09-26
• Date Added to Maude: 2006-08-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SCREW AND LOC VIAL SYSTEM
• Generic Name: PRESCRIPTION VIAL
• Product Code: NXB
• Date Received: 2005-11-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 736414
• Manufacturer: OWENS ILLINOIS
• Manufacturer Address: * BERLIN OH * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-11-02