Brand Name | AIRCAST AIRSELECT |
Type of Device | ORTHOSIS, CORRECTIVE SHOE |
Manufacturer (Section D) |
DJO LLC |
1430 decision street |
vista CA 92081 |
|
Manufacturer (Section G) |
DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V. |
carretera libre tijuana tecate |
20230 submetropoli el florido |
tijuana, b.c. 22244 |
MX
22244
|
|
Manufacturer Contact |
jim
pomeroy
|
1430 decision stree |
vista, CA 92081
|
5128346301
|
|
MDR Report Key | 11381829 |
MDR Text Key | 233724305 |
Report Number | 9616086-2021-00002 |
Device Sequence Number | 1 |
Product Code |
KNP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | N/A#S-P#N/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/22/2021 |
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 |
Lay User/Patient
|
Device Model Number | 01EP-M |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/26/2021 |
Initial Date FDA Received | 02/25/2021 |
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 |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 22 YR |