MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANT manufactured by Biofilm Inc..
[135572432]
I used the ultra-gel personal lubricant from astroglide. I applied it to my fianc? And when he was inserted, it burned me. He felt the warming feeling also. I am still inflamed a day later. Is the product over -the -counter? Yes, how was taken or used: topical, date the person first started taking or using the product: (b)(6) 2019. Date the person stopped taking or using the product: (b)(6) 2019. Why was the person using the product? Personal dryness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083860 |
| MDR Report Key | 8321910 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-02-06 |
| Date Added to Maude | 2019-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANT |
| Generic Name | LUBRICANT, PERSONAL |
| Product Code | NUC |
| Date Received | 2019-02-08 |
| Lot Number | A011267 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOFILM INC. |
| Manufacturer Address | VISTA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-08 |