Brand Name | SOLO PLUS HYBRID GUIDEWIRE |
Type of Device | ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY |
Manufacturer (Section D) |
HERAEUS MEDICAL COMPONENTS, LLC |
2605 fernbrook lane north |
suite j |
plymouth MN 55447 |
|
Manufacturer Contact |
chelsea
becker
|
2605 fernbrook lane n |
suite j |
plymouth, MN 55447
|
7632526500
|
|
MDR Report Key | 8813191 |
MDR Text Key | 151776804 |
Report Number | 2135342-2019-00001 |
Device Sequence Number | 1 |
Product Code |
OCY
|
UDI-Device Identifier | 00816840020326 |
UDI-Public | (01)00816840020326(17)200308(10)MO44542 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/11/2019 |
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 Model Number | HW38SA |
Device Catalogue Number | HW38SA |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/14/2019
|
Initial Date FDA Received | 07/22/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/28/2017 |
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) |
Required Intervention;
|