MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-15 for LATITUDE COMMUNICATOR 6468 manufactured by Plexus.
[179430897]
This investigation is complete. Should additional information become available this investigation will be updated.
Patient Sequence No: 1, Text Type: N, H10
[179430898]
It was reported that there was a burning smell from this communicator. The patient unplugged the communicator and the smell was gone. It was advised to replace the communicator and send back for analysis. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2019-24147 |
| MDR Report Key | 9592546 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-10-07 |
| Date Mfgr Received | 2019-10-07 |
| Date Added to Maude | 2020-01-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATITUDE COMMUNICATOR |
| Generic Name | COMMUNICATOR |
| Product Code | OSR |
| Date Received | 2020-01-15 |
| Model Number | 6468 |
| Catalog Number | 6468 |
| Lot Number | 100558 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLEXUS |
| Manufacturer Address | 2400 MILLBROOK DR BUFFALO GROVE IL 60089 US 60089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |