MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-07-13 for U BY KOTEX OVERNIGHT manufactured by Kimberly-clark Personal Hygienic Products Co., Lt.
[3572857]
The consumer stated that she developed a boil on her labia after menstrual pad usage. The consumer indicated that she frequently changed her pad due to heavy menstrual flow. Several days after usage, she developed tenderness on her labia. She later developed a boil on her labia which caused her severe pain and impaired her ability to walk. She visited the emergency room and her physician drained the boil and prescribed her antiobiotics. She stated that her physician believed her boil was related to the dry weave on the pad.
Patient Sequence No: 1, Text Type: D, B5
[11039964]
Device history record is under review. Information from this incident will be included in our product complaint and mdr trend analysis. Consumer returned unused product for evaluation and an investigation is underway.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615625-2013-00001 |
| MDR Report Key | 3225549 |
| Report Source | 04 |
| Date Received | 2013-07-13 |
| Date of Report | 2013-06-13 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2013-07-10 |
| Device Manufacturer Date | 2010-10-29 |
| Date Added to Maude | 2013-07-15 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARNELLE THOMAS |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD. |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 6783526031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | U BY KOTEX OVERNIGHT |
| Generic Name | UNSCENTED MENSTRUAL PADS |
| Product Code | HHD |
| Date Received | 2013-07-13 |
| Returned To Mfg | 2013-06-27 |
| Lot Number | BJ130209X0019 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO., LT |
| Manufacturer Address | BEIJING MILL NO. 2 JIAN'AN ST. BEIJING, 100176 CH 100176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-13 |