Brand Name | CRAFTMATIC MODEL 1 BASE |
Type of Device | BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE |
Manufacturer (Section D) |
CRAFTMATIC INDUSTRIES, INC. |
7411 fisher island drive |
miami beach FL 33019 0700 |
|
Manufacturer (Section G) |
CRAFTMATIC INDUSTRIES, INC. |
7411 fisher island drive |
|
miami beach FL 33019 0700 |
|
Manufacturer Contact |
jessica
vivar
|
7411 fisher island drive |
miami beach, FL 33019-0700
|
9548280893
|
|
MDR Report Key | 6750365 |
MDR Text Key | 81377302 |
Report Number | 3008872045-2017-00010 |
Device Sequence Number | 1 |
Product Code |
LLI
|
Combination Product (y/n) | N |
PMA/PMN Number | K022387 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
05/15/2017 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 4AM663 |
Device Catalogue Number | CMMOD1 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/01/2017
|
Initial Date FDA Received | 07/28/2017 |
Was Device Evaluated by Manufacturer? |
No
|
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) |
Other;
|
|
|