MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-29 for PROVOX VOICE PROSTHESIS RA7201 manufactured by Atos Medical Ab..
[16303]
Prosthesis became lodged during insertion. Tab tore off necessitating removal in or. Co has received a complaint regarding a torn off insertion tail on a voice prosthesis. The tail has torn off when the prosthesis was drawn through the esophagus towards the fistula. The dr claims that the prosthesis was stuck after which he pulled until the tail broke off. Co has investigated the prosthesis, especially with regard to the fractured surfaces. The fractured surface was strikingly irregularly toothed with defined marks, which definitely do not correspond with fractured surfaces arisen from fractures by pulling. With regard to the fractured surface, the tail has probably been deformed by some sharp instrument like for instance hemastatic forceps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824231-1995-00001 |
| MDR Report Key | 29715 |
| Date Received | 1995-12-29 |
| Date of Report | 1995-09-29 |
| Date of Event | 1995-09-27 |
| Date Facility Aware | 1995-09-29 |
| Report Date | 1995-09-29 |
| Date Reported to FDA | 1995-09-29 |
| Date Reported to Mfgr | 1995-09-29 |
| Date Added to Maude | 1996-02-08 |
| 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 | PROVOX VOICE PROSTHESIS |
| Generic Name | ARTIFICIAL LARYNX |
| Product Code | ESE |
| Date Received | 1995-12-29 |
| Catalog Number | RA7201 |
| Lot Number | 8702/950635 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30802 |
| Manufacturer | ATOS MEDICAL AB. |
| Manufacturer Address | KRAFTGATAN 8 PO BOX 183 HORBY SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-12-29 |