Brand Name | PLAYTEX SIMPLY GENTLE GLIDE |
Type of Device | TAMPON, MENSTRUAL, UNSCENTED |
Manufacturer (Section D) |
EDGEWELL PERSONAL CARE BRANDS, LLC / PLAYTEX MANUFACTURING INC. |
|
|
MDR Report Key | 8894093 |
MDR Text Key | 154761426 |
Report Number | MW5089023 |
Device Sequence Number | 1 |
Product Code |
HEB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
08/09/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/13/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
Yes
|
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 36 YR |
Patient Weight | 93 |
|
|