Brand Name | POISE IMPRESSA : PESSARY, VAGINAL : HHW |
Type of Device | PESSARY, VAGINAL |
Manufacturer (Section D) |
K-C AFC MANUFACTURING, S. DE R.L. DE C.V |
calzada industrial de las maquiladoras #87 |
nuevo nogales |
nogales, sonora mexico 84094 |
MX 84094 |
|
MDR Report Key | 11318063 |
MDR Text Key | 231701723 |
Report Number | 3011109575-2021-00037 |
Device Sequence Number | 1 |
Product Code |
HHW
|
UDI-Device Identifier | 00036000496192 |
UDI-Public | 036000496192 |
Combination Product (y/n) | N |
PMA/PMN Number | K131198 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial,Followup |
Report Date |
02/11/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/11/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | SIZE 2 |
Device Lot Number | NN921871A01062023 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/12/2021 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/12/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 64 YR |
|
|