MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-20 for E-A-RLINK EARTIP 420-2006 manufactured by 3m.
Report Number | MW5087523 |
MDR Report Key | 8722950 |
Date Received | 2019-06-20 |
Date of Report | 2019-05-24 |
Date of Event | 2019-05-22 |
Date Added to Maude | 2019-06-21 |
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 | 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-A-RLINK EARTIP |
Generic Name | CUSHION, EARPHONE (FOR AUDIOMETRIC TESTING) |
Product Code | ETT |
Date Received | 2019-06-20 |
Model Number | 420-2006 |
Catalog Number | 420-2006 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | 3M |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-06-20 |