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 LUBRICATING JELLY MDS032290 manufactured by Medline Industries, Inc..
[110486756]
Patient Sequence No: 1, Text Type: N, H10
[110486757]
I went through the results in basket and processed pap smear results, finding 7 pap smears which returned with no diagnosis and/or scant cellularity. This was an unusually high number of no diagnosis pap smears, as we typically have 1 or 2 in a month. I sent them over to the respective providers. Dr. Called me back and said something was wrong for there to be that many with no diagnosis. Dr. Said he spoke with pathology and that they agreed to re-review the pap smears.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7582181 |
| MDR Report Key | 7582181 |
| Date Received | 2018-06-08 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-24 |
| 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 LUBRICATING JELLY |
| Generic Name | LUBRICANT, PATIENT |
| Product Code | KMJ |
| Date Received | 2018-06-08 |
| Catalog Number | MDS032290 |
| Lot Number | 8A078 AND 71042 |
| 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 |