Type of Device | KIMGUARD ONESTEP STERILIZATION WRAP |
Manufacturer (Section D) |
HALYARD HEALTH |
5405 windward parkway |
alpharetta GA 30004 |
|
Manufacturer (Section G) |
HALYARD NORTH CAROLINA, INC. |
389 clyde fitzgerald road |
|
linwood NC 27299 |
|
Manufacturer Contact |
lisa
clark
|
5405 windward parkway |
alpharetta, GA 30004
|
4704485444
|
|
MDR Report Key | 5660603 |
MDR Text Key | 46579912 |
Report Number | 1054380-2016-00001 |
Device Sequence Number | 1 |
Product Code |
FRG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK082177 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/21/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/17/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other Health Care Professional
|
Device Expiration Date | 02/24/2020 |
Device Model Number | 34198 |
Device Catalogue Number | 991034198 |
Device Lot Number | LR5055 |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/29/2016 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/21/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/24/2015 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |