MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-09-12 for manufactured by .
[91089]
At the time of the distributor's mdr filing, the pt was still in the hospital, but had been extubated and was recovering. The facility did not report there was a problem with the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-1997-01900 |
| MDR Report Key | 119456 |
| Report Source | 08 |
| Date Received | 1997-09-12 |
| Date Mfgr Received | 1997-08-16 |
| Date Added to Maude | 1997-09-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | CAO |
| Date Received | 1997-09-12 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 117118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-09-12 |