FDA Adverse Event
Injury
Summary report: N
9617604-2008-00091
MDR report key: 1083409
·
Received July 18, 2008
Report
- Report Number
- 9617604-2008-00091
- Event Type
- Injury
- Date Received
- July 18, 2008
- Product Code
- CAH
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
RESULTS EVALUATIONS (OTHER): THIS REPORT IS STILL UNDER INVESTIGATION. THE USER FACILITY IS IN THE PROCESS OF OBTAINING AS MUCH DETAIL AS POSSIBLE. WE CAN REPORT THAT THIS FACILITY IS THE ONLY FACILITY THAT WE HAVE RECEIVED THIS REPORT FROM. WE DO KNOW THAT THEY RECENTLY CHANGED FROM A DIFFERENT STYLE HME AND WE ARE NOT SURE IF THIS HME IS THE RIGHT STYLE FOR THEIR APPLICATION. UPON RECEIPT OF THE COMPLETED INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |