MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-12-24 for BARALYME 44-01-0005 manufactured by Allied Healthcare Products, Inc..
[349842]
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
| Report Number | 1924066-2003-00009 |
| MDR Report Key | 506632 |
| Report Source | 05,06 |
| Date Received | 2003-12-24 |
| Date of Report | 2003-12-20 |
| Date of Event | 2003-09-11 |
| Date Mfgr Received | 2003-11-20 |
| Date Added to Maude | 2004-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1720 SUBLETTE AVE |
| Manufacturer City | ST. LOUIS MO 63110 |
| Manufacturer Country | US |
| Manufacturer Postal | 63110 |
| Manufacturer Phone | 3147712400 |
| Manufacturer G1 | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Street | KINDERHOOK & NEW STREET |
| Manufacturer City | STUYVESANT FALLS NY 12174 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12174 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARALYME |
| Generic Name | CARBON DIOXIDE ABSORBENT |
| Product Code | CBL |
| Date Received | 2003-12-24 |
| Model Number | 44-01-0005 |
| Catalog Number | 44-01-0005 |
| Lot Number | 18JUL051 |
| ID Number | * |
| Device Expiration Date | 2005-07-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 495508 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE. 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-24 |