MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2003-06-06 for REBREATHING BAG UNK manufactured by Rusch Manufacturing (uk).
[21247191]
Customer reports bag ripped during first time use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010092-2003-00063 |
| MDR Report Key | 465080 |
| Report Source | 08 |
| Date Received | 2003-06-06 |
| Date of Report | 2003-06-02 |
| Date Mfgr Received | 2003-06-02 |
| Date Added to Maude | 2003-06-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROLANDA SCOTT |
| Manufacturer Street | 2450 MEADOWBROOK PARKWAY |
| Manufacturer City | DULUTH GA 30136 |
| Manufacturer Country | US |
| Manufacturer Postal | 30136 |
| Manufacturer Phone | 7706230816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REBREATHING BAG |
| Generic Name | ANESTHESIA |
| Product Code | BYW |
| Date Received | 2003-06-06 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | 3J204 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 454005 |
| Manufacturer | RUSCH MANUFACTURING (UK) |
| Manufacturer Address | PORTADOWN RD., LURGAN, CRAIGAVON CO. ARMAGH, N. IRELAND UK BT66 8RD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-06-06 |