Brand Name | SWISH¿ DUO-GRIP¿ HEALING COLLAR |
Type of Device | HEALING COLLAR |
Manufacturer (Section D) |
IMPLANT DIRECT SYBRON MANUFACTURING, LLC |
3050 e. hillcrest drive |
thousand oaks CA 91362 |
|
Manufacturer Contact |
leopoldo
meza
|
3050 e. hillcrest drive |
thousand oaks, CA 91362
|
8184443300
|
|
MDR Report Key | 6679142 |
MDR Text Key | 78908165 |
Report Number | 3001617766-2017-00003 |
Device Sequence Number | 1 |
Product Code |
NHA
|
UDI-Device Identifier | 10841307115861 |
UDI-Public | 10841307115861 |
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | K090234 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
06/26/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 9048-13H |
Device Catalogue Number | 9048-13H |
Device Lot Number | 81080 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/06/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/09/2017 |
Initial Date FDA Received | 06/29/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/27/2016 |
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 |
|
|