MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-20 for GRONINGEN VOICE PROSTHESIS 441300 GH-013 manufactured by Medin Instruments B.v..
[239042]
The physician was inserting a voice prosthesis into a tracheo-esophageal fistula. The insertion string separated from the voice prosthesis, which remained in the esophagus. The voice prosthesis was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220850-2001-00001 |
| MDR Report Key | 367755 |
| Date Received | 2001-12-20 |
| Date Facility Aware | 2001-11-21 |
| Date Reported to Mfgr | 2001-12-03 |
| Date Added to Maude | 2001-12-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRONINGEN VOICE PROSTHESIS |
| Generic Name | VOICE PROSTHESIS |
| Product Code | MCK |
| Date Received | 2001-12-20 |
| Model Number | 441300 |
| Catalog Number | GH-013 |
| Lot Number | 39010 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 356876 |
| Manufacturer | MEDIN INSTRUMENTS B.V. |
| Manufacturer Address | VAN LENNEPLAAN 15 GRONINGEN NL 9721 PC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-12-20 |