Brand Name | ACP KIT SERIES I |
Type of Device | SYRINGE, PISTON |
Manufacturer (Section D) |
ARTHREX INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 1945 |
|
Manufacturer Contact |
vik
bajnath, adverse events
|
1370 creekside boulevard |
naples, FL 34108-1945
|
8009337013
|
|
MDR Report Key | 7321372 |
MDR Text Key | 101960266 |
Report Number | 1220246-2018-00080 |
Device Sequence Number | 1 |
Product Code |
FMF
|
UDI-Device Identifier | 00888867001824 |
UDI-Public | 00888867001824 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | BK070069 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/07/2018 |
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 |
Health Professional
|
Device Expiration Date | 06/01/2019 |
Device Catalogue Number | ABS-10011 |
Device Lot Number | 718875528 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/13/2018 |
Initial Date FDA Received | 03/07/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2017 |
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 |
Patient Outcome(s) |
Other;
|
|
|