MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-15 for ANESTHESIA MASKS manufactured by Medline Industries, Inc..
Report Number | 8896327 |
MDR Report Key | 8896327 |
Date Received | 2019-08-15 |
Date of Report | 2019-08-06 |
Date of Event | 2019-07-15 |
Report Date | 2019-08-07 |
Date Reported to FDA | 2019-08-07 |
Date Reported to Mfgr | 2019-08-15 |
Date Added to Maude | 2019-08-15 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
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 | ANESTHESIA MASKS |
Generic Name | MASK, GAS, ANESTHETIC |
Product Code | BSJ |
Date Received | 2019-08-15 |
Returned To Mfg | 2019-07-18 |
Lot Number | 40019030108 |
Device Availability | R |
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 | 2019-08-15 |