MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-12-14 for U BY KOTEX OVERNIGHT MENSTRUAL PADS manufactured by Kimberly-clark Personal Products, Ltd. Beijing.
[1744196]
Consumer had an allergic reaction while using overnight menstrual pads. The consumer visited the hospital er twice for treatment of rash and hives of the inner thighs, legs, and abdomen and other parts of her body.
Patient Sequence No: 1, Text Type: D, B5
[8825949]
Samples were not returned for inspection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615625-2010-00001 |
| MDR Report Key | 1933814 |
| Report Source | 04 |
| Date Received | 2010-12-14 |
| Date of Report | 2010-11-18 |
| Date of Event | 2009-11-17 |
| Date Mfgr Received | 2010-11-18 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2010-12-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LORI BARR |
| Manufacturer Street | 2001 MARATHON AVE. |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207214570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | U BY KOTEX OVERNIGHT MENSTRUAL PADS |
| Generic Name | HEB - UNSCENTED MENSTRUAL PADS |
| Product Code | HHD |
| Date Received | 2010-12-14 |
| Model Number | OVERNIGHT |
| Lot Number | BJ006005X0238 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK PERSONAL PRODUCTS, LTD. BEIJING |
| Manufacturer Address | NO.2 JIANAN ST. ECONOMIC TECH DEVELOPMENT ZONE BEIJING 100176 CH 100176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-14 |