MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-11-16 for BLOM-SINGER ADVANTAGE INDWELLING VOICE PROSTHESIS AD2012-NS manufactured by Freudenberg Medical, Llc Dba Helix Medical, Llc.
[31320007]
Patient Sequence No: 1, Text Type: N, H10
[31320008]
On (b)(4) 2015: the patient sent an email to freudenberg medical stating they had 2 emergency room visits to find where their indwelling voice prosthesis had gone. They initially went to the emergency room and they took x-rays and they could not see it. "they assumed it went down the esophagus even though" the patient stated they were "breathing heavily. " the patient returned to the emergency room. The doctor listened to their lungs and "could tell something was wrong by the right lung. " a cat scan was done which showed "where it was located. " the pulmonologist took the patient to the operating room, gave the patient anesthesia and removed it. The removed device was given to the patient who noted that one of the flanges was missing. On (b)(4) 2015: an slp from freudenberg medical spoke to the patient and the following information was provided: patient "is in good health - no adverse health issues as a result of the incident. " product was placed in (b)(6) 2014. Timeline/events per patient report: approximately 1 week before the prosthesis reportedly dislodged, they "experienced some gastric issues" which they "now retrospectively think was related to the esophageal flange falling off and passing through" their digestive system. During that same week, the patient noticed that the voice prosthesis appeared to be pistoning. The "valve dislodged" and the patient placed a patient changeable voice prosthesis. The patient had a chest x-ray which was negative. The patient felt short of breath and called slps who told them to go for further evaluation as it was possible that the aspirated prosthesis did not show up on the x-ray. The patient had a ct of the lung which showed the presence of the prosthesis in their airway. The patient underwent a bronchoscopy and a pulmonologist removed the prosthesis. Subsequently, the patient was in good health. On 9/4/2015: device was received at freudenberg medical with a note from the patient which stated: "enclosed is defective advantage indwelling. Removed with bronchoscope by pulmonologist... On (b)(6) 2015. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2015-00005 |
| MDR Report Key | 5227133 |
| Report Source | CONSUMER |
| Date Received | 2015-11-16 |
| Date of Report | 2015-11-16 |
| Date of Event | 2015-08-08 |
| Date Mfgr Received | 2015-08-10 |
| Date Added to Maude | 2015-11-16 |
| 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 DBA HELIX MEDICAL, LLC |
| Manufacturer Street | 1110 MARK AVENUE |
| Manufacturer City | CARPINTERIA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER ADVANTAGE INDWELLING VOICE PROSTHESIS |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2015-11-16 |
| Returned To Mfg | 2015-09-04 |
| Model Number | AD2012-NS |
| Catalog Number | AD2012-NS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREUDENBERG MEDICAL, LLC DBA HELIX MEDICAL, LLC |
| Manufacturer Address | 1110 MARK AVENUE CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-11-16 |