Brand Name | KINCISE CUP-ADAPTER-PINNACLE STRAIGHT |
Type of Device | IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER |
Manufacturer (Section D) |
DEPUY SYNTHES PRODUCTS LLC |
4500 riverside drive |
palm beach gardens FL 33410 |
|
Manufacturer (Section G) |
TECHTRONIC INDUSTRIES MEDICAL |
1428 pearman dairy rd |
|
anderson SC 29625 |
|
Manufacturer Contact |
kara
ditty-bovard
|
4500 riverside drive |
palm beach gardens, FL 33410
|
6103142063
|
|
MDR Report Key | 8890055 |
MDR Text Key | 154556252 |
Report Number | 1045834-2019-54287 |
Device Sequence Number | 1 |
Product Code |
GEY
|
UDI-Device Identifier | 00850915006099 |
UDI-Public | 850915006099 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/12/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/13/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 1011-01-101 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/18/2019 |
Date Manufacturer Received | 08/08/2019 |
Date Device Manufactured | 06/18/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |