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 |
|
Manufacturer (Section G) |
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
|
|
Manufacturer Contact |
emily
arnould, rn bsn
|
2100 winchester rd |
neenah, WI 54956
|
9207213128
|
|
MDR Report Key | 14213567 |
MDR Text Key | 290149546 |
Report Number | 3011109575-2022-00168 |
Device Sequence Number | 1 |
Product Code |
HHW
|
UDI-Device Identifier | 00036000496185 |
UDI-Public | 036000496185 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131198 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/26/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | SIZE 1 |
Device Lot Number | NN029671A |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/01/2022 |
Initial Date FDA Received | 04/26/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/22/2020 |
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 Age | 63 YR |
Patient Sex | Female |
|
|