MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2008-09-03 for manufactured by .
[15990522]
The prismaflex machine in use at the time of the reported event has been used after the reported event with no problems. A gambro rep has not inspected the prismalflex machine, since there were no reported problems, prior to the decision to terminate treatment. It is a gambro policy, that all deaths occurring during or within 24 hours after treatment, regardless of cause, shall be reported. Gambro has found no evidence to suggest that its device caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2008-00013 |
| MDR Report Key | 1150323 |
| Report Source | 01,05,06 |
| Date Received | 2008-09-03 |
| Date Mfgr Received | 2008-08-06 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2008-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MIKAEL HENNINGSSON |
| Manufacturer Street | BOX 10101 |
| Manufacturer City | LUND SE-22010 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-22010 |
| Manufacturer Phone | 6169000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MQS |
| Date Received | 2008-09-03 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1166498 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-03 |