MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-02-18 for REBREATHING BAG (OVAL SHAPE) 2107602 manufactured by Rusch Mfg. Uk, Ltd..
[175172]
It was reported that the device, after repeated use, developed a hole while being cleaned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010092-1999-00009 |
| MDR Report Key | 211180 |
| Report Source | 04 |
| Date Received | 1999-02-18 |
| Date of Report | 1999-02-18 |
| Date Mfgr Received | 1999-02-04 |
| Date Added to Maude | 1999-02-25 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REBREATHING BAG (OVAL SHAPE) |
| Generic Name | BREATHING BAG |
| Product Code | BYW |
| Date Received | 1999-02-18 |
| Model Number | NA |
| Catalog Number | 2107602 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 204929 |
| Manufacturer | RUSCH MFG. UK, LTD. |
| Manufacturer Address | PORTADOWN RD. LURGAN CO. ARMAGH NORTHERN IRELAND UK BT66 8RD |
| Baseline Brand Name | REBREATHING BAG |
| Baseline Generic Name | BREATHING BAG |
| Baseline Model No | NA |
| Baseline Catalog No | 2107602 |
| Baseline ID | NA |
| Baseline Device Family | BREATHING BAG |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-02-18 |