MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for U TAMPONS REGUAL KOTEX manufactured by Kimberly-clark Corp.
[135889250]
Sepsis toxic shock. Is the product over-the-counter? Yes. Did the problem stop after the person reduced the dose or stopped taking or using the product again? Doesn't apply. Do you still have the product in case we need to evaluate it? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083853 |
| MDR Report Key | 8320810 |
| Date Received | 2019-02-07 |
| Date of Event | 2018-03-08 |
| Date Added to Maude | 2019-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | U TAMPONS REGUAL KOTEX |
| Generic Name | PAD, MENSTRUAL, UNSCENTED |
| Product Code | HHD |
| Date Received | 2019-02-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2019-02-07 |