Brand Name | TRIADYNEPROVENTA |
Type of Device | BED, PATIENT ROTATION, POWERED |
Manufacturer (Section D) |
ARJOHUNTLEIGH, INC. |
4958 stout drive |
san antonio TX 78219 |
|
MDR Report Key | 12238155 |
MDR Text Key | 263814882 |
Report Number | 3007420694-2021-00107 |
Device Sequence Number | 1 |
Product Code |
IKZ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Type of Report
| Initial,Followup |
Report Date |
08/24/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Device Model Number | 406000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/29/2021 |
Initial Date Manufacturer Received |
06/28/2021
|
Initial Date FDA Received | 07/28/2021 |
Supplement Dates Manufacturer Received | 06/28/2021
|
Supplement Dates FDA Received | 08/24/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
|
|