MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-15 for DYNJ906040A manufactured by Medline Industries Inc..
Report Number | 1423395-2019-00036 |
MDR Report Key | 9192053 |
Date Received | 2019-10-15 |
Date of Report | 2019-10-15 |
Date of Event | 2019-08-13 |
Date Mfgr Received | 2019-09-24 |
Date Added to Maude | 2019-10-15 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | BERMON PUNZALAN |
Manufacturer Street | THREE LAKES DRIVE |
Manufacturer City | NORTHFIELD IL 60093 |
Manufacturer Country | US |
Manufacturer Postal | 60093 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Generic Name | #11 SURGICAL BLADE IN ARTHROSCOPY PACK |
Product Code | OJH |
Date Received | 2019-10-15 |
Catalog Number | DYNJ906040A |
Lot Number | UNK |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
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 | 1. Required No Informationntervention | 2019-10-15 |