MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-25 for MEDLINE PELVIC EXAM TRAY DYNE1045 DYNDE1045 manufactured by Medline Industries Inc..
Report Number | MW5090678 |
MDR Report Key | 9244632 |
Date Received | 2019-10-25 |
Date of Report | 2019-10-23 |
Date of Event | 2019-10-23 |
Date Added to Maude | 2019-10-28 |
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 | OTHER HEALTH CARE PROFESSIONAL |
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 | MEDLINE PELVIC EXAM TRAY |
Generic Name | PELVIC EXAM KIT |
Product Code | MLT |
Date Received | 2019-10-25 |
Model Number | DYNE1045 |
Catalog Number | DYNDE1045 |
Lot Number | 2018112090 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDLINE INDUSTRIES INC. |
Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
Brand Name | MEDLINE PELVIC EXAM TRAY |
Generic Name | PELVIC EXAM KIT |
Product Code | MLT |
Date Received | 2019-10-25 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | MEDLINE INDUSTRIES, INC. |
Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
Brand Name | MEDLINE PELVIC EXAM TRAY |
Generic Name | PELVIC EXAM KIT |
Product Code | MLT |
Date Received | 2019-10-25 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 3 |
Device Event Key | 0 |
Manufacturer | MEDLINE INDUSTRIES, INC. |
Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-10-25 |