MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-11 for BLOM-SINGER CLASSIC INDWELLING VOICE PROSTHESIS IN 2010-LEF IN 2012-LEF manufactured by Freudenberg Medical, Llc D.b.a. Helix Medical, Llc.
[38084817]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[38084818]
While patient was in the hospital in icu because of pneumonia, the voice prosthesis was aspirated. An ent doctor performed a procedure to retrieve the device from the lungs. The doctor was able to re-insert the device in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2016-00001 |
| MDR Report Key | 5432374 |
| Date Received | 2016-02-11 |
| Date of Report | 2016-02-11 |
| Date of Event | 2016-01-28 |
| Date Mfgr Received | 2016-01-28 |
| Device Manufacturer Date | 2015-10-09 |
| Date Added to Maude | 2016-02-11 |
| 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 | MS. BELINDA JACKSON |
| Manufacturer Street | 1110 MARK AVENUE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055765308 |
| Manufacturer G1 | FREUDENBERG MEDICAL, LLC |
| Manufacturer Street | 1110 MARK AVENUE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLOM-SINGER CLASSIC INDWELLING VOICE PROSTHESIS |
| Generic Name | VOICE PROSTHESIS, PRODUCT CODE: EWL |
| Product Code | EWL |
| Date Received | 2016-02-11 |
| Model Number | IN 2010-LEF |
| Catalog Number | IN 2012-LEF |
| Lot Number | 0000014752 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREUDENBERG MEDICAL, LLC D.B.A. HELIX MEDICAL, LLC |
| Manufacturer Address | 1110 MARK AVENUE CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-11 |