MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-07 for ALWAYS PADS AND PANTYLINER manufactured by P And G.
[42533275]
Initially noted flat black moles along panty line bilateral. Largest approximately 2-3 cm in diameter located on the left, and the one on the right was approximately 1-2 with dark discoloration of the inner labia in multiple areas. Followed up with ob/gyn (b)(6) 2015, initial biopsy obtained resulted (b)(6) 2016 squamous cell carcinoma (vulva cancer). At age (b)(6), underwent surgery (wide resection modified vulvectomy) on (b)(6) 2016. Of note, no pre-existing factors noted i. E. No (b)(6), no genital warts, no multiple sexual partners. The only things constant in past 13 years is the use of always pads for initially menses, then urine leakage daily. The positioning of the cancerous lesions were along the area that the pad would come in contact with, the external labia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061621 |
| MDR Report Key | 5570241 |
| Date Received | 2016-04-07 |
| Date of Report | 2016-04-07 |
| Date of Event | 2015-10-20 |
| Date Added to Maude | 2016-04-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALWAYS PADS AND PANTYLINER |
| Generic Name | ALWAYS PADS AND PANTYLINER |
| Product Code | HHD |
| Date Received | 2016-04-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | P AND G |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-07 |