Brand Name | AHTB ACTIVE HEEL TRACTION BOOT |
Type of Device | APPARATUS, TRACTION, NON-POWERED |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
150 minuteman road |
andover MA 01810 |
|
MDR Report Key | 7362912 |
MDR Text Key | 103321210 |
Report Number | 3003604053-2018-00048 |
Device Sequence Number | 1 |
Product Code |
HST
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
05/16/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/22/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 72202682 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/24/2018 |
Date Manufacturer Received | 05/15/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|