MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-28 for MEDLINE PERSONAL CLEANING CLOTHES manufactured by Medline.
[18730333]
Caused vaginal irritation. Used (b)(6) 2012 for a few days. Will not use again. Still have product used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034111 |
| MDR Report Key | 3602173 |
| Date Received | 2014-01-28 |
| Date of Report | 2014-01-07 |
| Date of Event | 2012-02-01 |
| Date Added to Maude | 2014-02-03 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE PERSONAL CLEANING CLOTHES |
| Generic Name | CLEANING CLOTHES |
| Product Code | FRO |
| Date Received | 2014-01-28 |
| Lot Number | 5108 |
| Device Expiration Date | 2014-03-01 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Brand Name | ASTROGLIDE PERSONAL LUBRICANT |
| Generic Name | LUBRICANT |
| Product Code | KMJ |
| Date Received | 2014-01-28 |
| Lot Number | A003304 |
| Device Expiration Date | 2012-11-01 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BIOFILM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-28 |