Brand Name | S-VAC SILICONE BULB EVACUATOR, 100ML, STERILE |
Type of Device | WOUND DRAIN |
Manufacturer (Section D) |
ASPEN SURGICAL PRODUCTS, CALEDONIA |
6945 southbelt dr. s.e. |
caledonia MI 49316 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
jordan
hackert
|
6945 southbelt dr. s.e. |
caledonia, MI 49316
|
6165367508
|
|
MDR Report Key | 12206088 |
MDR Text Key | 264952574 |
Report Number | 1836161-2021-00031 |
Device Sequence Number | 1 |
Product Code |
GCY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/23/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/21/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 322160 |
Device Lot Number | 244964 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 06/23/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|