Brand Name | ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR |
Type of Device | ELASTOMERIC - SAF |
Manufacturer (Section D) |
AVANOS MEDICAL INC. |
5405 windward parkway |
alpharetta GA 30004 |
|
Manufacturer (Section G) |
AVENT S. DE R.L. DE C.V. |
ave noruega edificio d-1b |
fraccionamiento rubio |
tijuana b.c. 22116 |
MX
22116
|
|
Manufacturer Contact |
lisa
clark
|
5405 windward parkway |
alpharetta, GA 30004
|
4704485444
|
|
MDR Report Key | 11793031 |
MDR Text Key | 261537212 |
Report Number | 2026095-2021-00056 |
Device Sequence Number | 1 |
Product Code |
MEB
|
UDI-Device Identifier | 00193494134761 |
UDI-Public | 00193494134761 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K063530 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
05/07/2021 |
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 |
Lay User/Patient
|
Device Expiration Date | 02/03/2023 |
Device Model Number | CB6004 |
Device Catalogue Number | N/A |
Device Lot Number | 20035683 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/15/2021 |
Initial Date FDA Received | 05/07/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/15/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 41 YR |
Patient Weight | 101 |