Brand Name | HANDICARE |
Type of Device | STAIR CHAIR LIFT |
Manufacturer (Section D) |
HANDICARE STAIRLIFTS B.V. |
newtonstraat 35 |
po box 39 |
heerhugowaard, noord holland 1700 AA |
NL 1700 AA |
|
Manufacturer (Section G) |
HANDICARE |
newtonstraat 35 |
po box 39 |
heerhugogaard, noord holland 1700 AA |
NL
1700 AA
|
|
Manufacturer Contact |
peter
laan
|
newtonstraat 35 |
po box 39 |
heerhugowaard, noord holland 1700 -AA
|
NL
1700 AA
|
|
MDR Report Key | 17785884 |
MDR Text Key | 323892082 |
Report Number | 3013423626-2023-00001 |
Device Sequence Number | 1 |
Product Code |
PCD
|
UDI-Device Identifier | 8719326254326 |
UDI-Public | 018719326254326 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/22/2024 |
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 Model Number | 1100 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/15/2023 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/08/2023
|
Initial Date FDA Received | 09/20/2023 |
Supplement Dates Manufacturer Received | 09/08/2023
|
Supplement Dates FDA Received | 03/22/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 72 YR |
Patient Sex | Male |
|
|