MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-09-27 for KOTEX ULTRATHIN MAXI PADS ULTRA THIN manufactured by Kimberly-clark Corporation - Conway Mill.
[19731831]
The consumer stated that she developed a boil on her labia after menstrual pad usage. She indicated that she is allergic to adhesive, bananas, latex and bandages. She has used kotex for over 6 years and would develop small bumps around the adhesive after usage. In this past month she developed a quarter-size bump which later developed into a boil. She visited her doctor on (b)(6) 2013 and the boil was lanced and drained pus and blood. She was prescribed cephalexin and is taking advil for pain. She has discontinued use of the product.
Patient Sequence No: 1, Text Type: D, B5
[19760488]
Device history record could not be reviewed as lot code was not provided. Information from this incident will be included in our product complaint and mdr trend analysis. Consumer had not returned unused product for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2381757-2013-00039 |
| MDR Report Key | 3373138 |
| Report Source | 04 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-09-10 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2013-09-10 |
| Date Added to Maude | 2013-09-27 |
| 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 | KOTEX ULTRATHIN MAXI PADS |
| Generic Name | MENSTRUAL PAD |
| Product Code | HHD |
| Date Received | 2013-09-27 |
| Model Number | ULTRA THIN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORPORATION - CONWAY MILL |
| Manufacturer Address | 480 EXCHANGE AVE. CONWAY AR 72032719 US 72032 7191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-27 |