MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-07-03 for RUSCH 395940 manufactured by Rusch, Inc..
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Broke apart during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-2002-00133 |
| MDR Report Key | 403956 |
| Report Source | 05,06 |
| Date Received | 2002-07-03 |
| Date of Report | 2002-07-02 |
| Date Mfgr Received | 2002-07-02 |
| Date Added to Maude | 2002-07-11 |
| 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 | CASSANDRA BATTLE, TECHNICIAN II |
| Manufacturer Street | 2450 MEADOWBROOK PARKWAY |
| Manufacturer City | DULUTH GA 30096 |
| Manufacturer Country | US |
| Manufacturer Postal | 30096 |
| 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 | RUSCH |
| Generic Name | RESPIRATORY |
| Product Code | CBP |
| Date Received | 2002-07-03 |
| Model Number | NA |
| Catalog Number | 395940 |
| Lot Number | 11393 AND 112514 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 392948 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | RUSCH |
| Baseline Generic Name | RESPIRATORY |
| Baseline Model No | NA |
| Baseline Catalog No | 395940 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-07-03 |