MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-21 for LUBRICATING JELLY manufactured by Henry Schein, Inc..
[118015974]
Reporter states that on (b)(6) 2018 she had a pap smear at her physician's office and had a very severe reaction to the lubrication used. Patient has a hx of vulvodynia and believes this event has caused a flareup. She goes on to say that these flareups feel like her "whole body is on fire" and could last years. She had to quit her job and is unsure what to do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079298 |
| MDR Report Key | 7805571 |
| Date Received | 2018-08-21 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-08-08 |
| Date Added to Maude | 2018-08-22 |
| 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 | LUBRICATING JELLY |
| Generic Name | LUBRICANT, PATIENT |
| Product Code | KMJ |
| Date Received | 2018-08-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HENRY SCHEIN, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-21 |