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 |