MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-08 for E-Z LUBRICANTING JELLY MDS032290 manufactured by Medline Industries, Inc..
[110485353]
Patient Sequence No: 1, Text Type: N, H10
[110485354]
Patient was undergoing pelvic exam by dr. Patient has been treated with prior radiation therapy to the vulva for vulvar cancer. Dr. Applied e-z lubricant to the vulva for the examination and the patient immediately began experiencing intense burning. Patient was given wipes to clean the skin and a peri bottle was obtained from distribution. Patient stated the burning sensation was gone after having thoroughly cleaned herself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7582230 |
| MDR Report Key | 7582230 |
| Date Received | 2018-06-08 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-23 |
| Report Date | 2018-05-29 |
| Date Reported to FDA | 2018-05-29 |
| Date Reported to Mfgr | 2018-05-29 |
| Date Added to Maude | 2018-06-08 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | E-Z LUBRICANTING JELLY |
| Generic Name | LUBRICANT, PATIENT |
| Product Code | KMJ |
| Date Received | 2018-06-08 |
| Catalog Number | MDS032290 |
| Lot Number | 8A078 |
| ID Number | RA16HND |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-08 |