MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for EZ LUBRICATING JELLY UNK manufactured by Medline Industries.
[89292265]
Patient Sequence No: 1, Text Type: N, H10
[89292266]
Ez lube is sold as a lubricant used readily in the outpatient setting. After years of using the product, we are making the full transition over to surgilube. It was found that a study from 2014 identified brands of lubricants that were not compatible with pap smear, thin prep. Further investigation identified that ez lube may cause the cells to clump and result in a higher percentage of unsatisfactory paps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6947967 |
| MDR Report Key | 6947967 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-07-03 |
| Report Date | 2017-09-25 |
| Date Reported to FDA | 2017-09-25 |
| Date Reported to Mfgr | 2017-09-25 |
| Date Added to Maude | 2017-10-13 |
| 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 | RISK MANAGER |
| 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 | EZ LUBRICATING JELLY |
| Generic Name | LUBRICANT, PATIENT, VAGINAL |
| Product Code | KMJ |
| Date Received | 2017-10-13 |
| Model Number | UNK |
| Lot Number | UNK |
| Device Expiration Date | 2019-08-08 |
| Device Availability | * |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-13 |