BARALYME * 44-01-0002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-16 for BARALYME * 44-01-0002 manufactured by Allied Healthcare Products, Inc. Chemetron Med Div.

Event Text Entries

[341106] Co2 absorbent canisters noted to be melted. Two (2) inch diameter hole in tops of canisters during routine weekly exchange of co2 absorbent.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030559
• MDR Report Key: 503345
• Date Received: 2003-12-17
• Date of Report: 2003-12-15
• Date of Event: 2003-09-11
• Date Added to Maude: 2003-12-31
• 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: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BARALYME
• Generic Name: CO2 ABSORBENT
• Product Code: CBL
• Date Received: 2003-10-16
• Model Number: *
• Catalog Number: 44-01-0002
• Lot Number: *
• ID Number: *
• Device Expiration Date: 2005-07-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 492120
• Manufacturer: ALLIED HEALTHCARE PRODUCTS, INC. CHEMETRON MED DIV
• Manufacturer Address: 1720 SUBLETTE AVENUE ST. LOUIS MO 63110 US

Device Sequence Number: 2

• Brand Name: BARALYME
• Generic Name: CO2 ABSORBENT
• Product Code: CBL
• Date Received: 2003-10-16
• Model Number: *
• Catalog Number: 44-01-0005
• Lot Number: *
• ID Number: *
• Device Expiration Date: 2005-07-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 492121
• Manufacturer: ALLIED HEALTHCARE PRODUCTS, INC. CHEMETRON MED DIV
• Manufacturer Address: 1720 SUBLETTE AVENUE ST. LOUIS MO 63110 US
• Baseline Brand Name: BARALYME
• Baseline Generic Name: CARBON DIXOIDE ABSORBENT
• Baseline Model No: 44-01-0005
• Baseline Catalog No: 44-01-0005
• Baseline Device Family: CARBON DIOXIDE ABSORBENT
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 24
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 3

• Brand Name: BARALYME
• Generic Name: CO2 ABSORBENT
• Product Code: CBL
• Date Received: 2003-10-16
• Model Number: *
• Catalog Number: 44-01-0009
• Lot Number: *
• ID Number: *
• Device Expiration Date: 2005-07-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 3
• Device Event Key: 492122
• Manufacturer: ALLIED HEALTHCARE PRODUCTS, INC. CHEMETRON MED DIV
• Manufacturer Address: 1720 SUBLETTE AVENUE ST. LOUIS MO 63110 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-12-17