Brand Name | DEROYAL |
Type of Device | BACK SUPPORT, PROLIGN® EXT, 25 DEGREE, BOA, M |
Manufacturer (Section D) |
DEROYAL INDUSTRIES, INC |
200 debusk ln |
powell TN 37849 |
|
Manufacturer (Section G) |
DEROYAL INDUSTRIES, INC. |
km7 autopista joaquin balaguer |
pisano free zone, building 18 |
santiago, |
DR
|
|
Manufacturer Contact |
marian
vargas
|
200 debusk ln |
powell, TN 37849
|
8653621013
|
|
MDR Report Key | 5240336 |
MDR Text Key | 32261301 |
Report Number | 3006851902-2015-00004 |
Device Sequence Number | 1 |
Product Code |
IPY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/20/2015 |
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 |
No Information
|
Device Model Number | 157-03 |
Device Lot Number | 30465618 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/03/2015 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 10/21/2015 |
Initial Date Manufacturer Received |
10/21/2015 |
Initial Date FDA Received | 11/20/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|