MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-08-22 for LIGHTDAYS PANTY LINERS REGULAR manufactured by Kimberly-clark Corporation - Conway Mill.
[21759713]
The consumer indicated she used a liner and developed a rash which created lesions. She visited her doctor who recommended she visit a specialist. She plans to visit a specialist and discontinue usage of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2381757-2012-00061 |
| MDR Report Key | 2708807 |
| Report Source | 04 |
| Date Received | 2012-08-22 |
| Date of Report | 2012-07-20 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2012-07-20 |
| Device Manufacturer Date | 2012-01-26 |
| Date Added to Maude | 2012-08-22 |
| 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 |
| 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 | LIGHTDAYS PANTY LINERS |
| Generic Name | MENSTRUAL PAD |
| Product Code | HHL |
| Date Received | 2012-08-22 |
| Model Number | REGULAR |
| Lot Number | AC202613X2054 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORPORATION - CONWAY MILL |
| Manufacturer Address | 480 EXCHANGE AVENUE CONWAY AR 72032719 US 72032 7191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-22 |