MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-11-15 for U BY KOTEX HEAVY FLOW WITH WINGS MENSTRUAL PAD HEAVY FLOW/WINGS manufactured by Kimberly-clark Personal Products, Ltd. Beijing.
[16188879]
Device history record in review. Info from this incident will be included in our product complaint and mdr trend analysis. Consumer had not returned unused product for eval at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[16319434]
Consumer stated she used a menstrual pad and experienced burning and went to the er. While at the er she was examined and indicated she was prescribed a cream for 1st degree burns. The 1st degree burn area blistered and some blisters opened. The consumer stated she will have scars.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615625-2011-00001 |
| MDR Report Key | 2384317 |
| Report Source | 04 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-10-25 |
| Date of Event | 2011-10-01 |
| Date Mfgr Received | 2011-10-25 |
| Date Added to Maude | 2012-07-16 |
| 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 HEAVY FLOW WITH WINGS MENSTRUAL PAD |
| Generic Name | UNSCENTED MENSTRUAL PADS |
| Product Code | HHD |
| Date Received | 2011-11-15 |
| Model Number | HEAVY FLOW/WINGS |
| Lot Number | BJ933177 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 TECHNOLOGY DEVL ZONE BEIJING 100176 CH 100176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-15 |