MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-28 for BLOM-SINGER BE 2026 manufactured by Freudenberg Medical, Llc.
[83833976]
The registered nurse/care coordinator reported that one of the patients at their hospital coughed while inserting a prosthesis and aspirated the device. The prosthesis has been removed from the patient. The nurse indicated that the device would not be returned for evaluation. Additional attempts were made to contact the nurse and patient; however, (b)(4) was unable to reach the nurse or patient for further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2017-00005 |
| MDR Report Key | 6826017 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-28 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-02 |
| Date Added to Maude | 2017-08-28 |
| 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 | JONATHAN LEE |
| Manufacturer Street | 1110 MARK AVENUE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2017-08-28 |
| Catalog Number | BE 2026 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREUDENBERG MEDICAL, LLC |
| Manufacturer Address | 1110 MARK AVENUE CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-28 |