MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-02-05 for RUSCH 2107102 manufactured by Rusch Manufacturing (uk).
[212691]
The customer reports that the bags are splitting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010092-2002-00026 |
| MDR Report Key | 376175 |
| Report Source | 06 |
| Date Received | 2002-02-05 |
| Date of Report | 2002-02-04 |
| Date Mfgr Received | 2002-02-01 |
| Date Added to Maude | 2002-02-13 |
| 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 | DONNA MCLEOD, QUALITY ADMIN |
| 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 | LATEX BREATHING BAG |
| Product Code | BYW |
| Date Received | 2002-02-05 |
| Model Number | NA |
| Catalog Number | 2107102 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 365261 |
| Manufacturer | RUSCH MANUFACTURING (UK) |
| Manufacturer Address | PORTADOWN RD., LURGAN, CRAIGAVON CO. ARMAGH, N. IRELAND UK BT66 8RD |
| Baseline Brand Name | LATEX BREATHING BAG |
| Baseline Generic Name | LATEX BREATHING BAG |
| Baseline Model No | NA |
| Baseline Catalog No | 2107102 |
| Baseline ID | NA |
| Baseline Device Family | BREATHING BAG |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-02-05 |