Brand Name | CRAFTMATIC MODEL 1 BASE |
Type of Device | BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE |
Manufacturer (Section D) |
CRAFTMATIC INDUSTRIES, INC. |
3580 gateway dr |
pompano beach FL 33069 |
|
Manufacturer (Section G) |
CRAFTMATIC INDUSTRIES, INC. |
3580 gateway dr |
|
pompano beach FL 33069 |
|
Manufacturer Contact |
jessica
vivar
|
5192 sw 27th ave |
ft. lauderdale, FL 33312
|
9548280893
|
|
MDR Report Key | 9272295 |
MDR Text Key | 166015259 |
Report Number | 3008872045-2019-00017 |
Device Sequence Number | 1 |
Product Code |
LLI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K022387 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
10/22/2019 |
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 |
Lay User/Patient
|
Device Model Number | 4AR794 |
Device Catalogue Number | CMMOD1 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/04/2019
|
Initial Date FDA Received | 11/04/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|