MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-02-10 for BLOM-SINGER * BE2022 manufactured by Inhealth Technologies, A Division Of Helix Medical, Inc..
[19495684]
Pt called to complaint that "glue was not sticking. " towards end of conversation pt stated that a voice prosthesis "fell down his lungs last week. " pt stated he "had to go to the hosp, be put to sleep and a mechanical device be put down his stomach to retrieve the prosthesis. " pt stated "the prosthesis is fine and it is the glue's fault this happened. " pt is still using the prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2006-00004 |
| MDR Report Key | 676069 |
| Report Source | 04 |
| Date Received | 2006-02-10 |
| Date of Report | 2006-02-10 |
| Date of Event | 2006-01-10 |
| Date Mfgr Received | 2006-01-10 |
| Date Added to Maude | 2006-02-16 |
| 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 | 0 |
| Manufacturer Street | 1110 MARK AVE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8056843304 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER |
| Generic Name | LOW PRESSURE VOICE PROSTHESIS |
| Product Code | MCK |
| Date Received | 2006-02-10 |
| Model Number | * |
| Catalog Number | BE2022 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 665347 |
| Manufacturer | INHEALTH TECHNOLOGIES, A DIVISION OF HELIX MEDICAL, INC. |
| Manufacturer Address | * CARPINTERIA CA * US |
| Baseline Brand Name | BLOM-SINGER |
| Baseline Generic Name | LOW PRESSURE VOICE PROSTHESIS |
| Baseline Model No | * |
| Baseline Catalog No | BE2022 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-02-10 |