MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-04-27 for BLOM-SINGER CLASSIC INDWELLING IN2006-NS manufactured by Helix Medical, Llc.
[18290181]
The patient's family called to report that the patient woke up without their voice prosthesis in place, and was unsure if it "fell out or was swallowed". The patient then had an x-ray performed the same day and confirmed the prothesis was not located in the lungs. The patient had a catheter placed and was scheduled to have a new voice prosthesis placed the next day. As the voice prosthesis cannot be located, it will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
[18649342]
The instructions for use (ifu) which accompany each product detail voice prosthesis dislodgement, and that: "care must be exercised during prosthesis insertion or removal to avoid injury to the tep or accidental displacement of the prothesis which could result in aspiration of the prosthesis into the trachea. " also detailed in complications section of the ifu warns of "ingestion of the prosthesis into the esophagus and/or gi tract". The prothesis will not be made available for evaluation as per the reported complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025182-2015-00003 |
| MDR Report Key | 4736234 |
| Report Source | 04 |
| Date Received | 2015-04-27 |
| Date of Report | 2015-04-24 |
| Date of Event | 2015-04-23 |
| Date Mfgr Received | 2015-04-23 |
| Date Added to Maude | 2015-04-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BELINDA JACKSON |
| Manufacturer Street | 1110 MARK AVE. |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055765308 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER CLASSIC INDWELLING |
| Product Code | EWL |
| Date Received | 2015-04-27 |
| Model Number | IN2006-NS |
| Catalog Number | IN2006-NS |
| Lot Number | 0000003154 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HELIX MEDICAL, LLC |
| Manufacturer Address | CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-27 |