MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-04-02 for PROVOX VOICE PROSTHESIS REF 7202 manufactured by Atos Medical Ab.
[827370]
According to the complaint: hospital found a hole in plastic cover, and the sterility was therefore ruined. They suspect that the scalpel inside has caused the hole.
Patient Sequence No: 1, Text Type: D, B5
[7994236]
Visual examination of the device packaging shows compression damage on both ends of the outer package indicating very rough handling of the package. The inner package is mainly intact apart from a hole at the center were the tip of the scalpel has penetrated the plastic container and a dent inwards on the package at the handle end of the scalpel. Postmarket surveillance shows that the current design of the package has been used since 1995 and large quanity of the devices have been distributed world wide. No previous complaints indicating any packaging is suitable for its intended use. The investigation has concluded that accidental and unforeseen shipping and/or handling damage of the outer carton has caused the damage to the device packaging. A caution on the packaging states that the product is sterile if the package is undamaged and since no previous complaints have been reported no further actions are taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2008-00002 |
| MDR Report Key | 1025316 |
| Report Source | 05,08 |
| Date Received | 2008-04-02 |
| Date of Report | 2008-03-25 |
| Date of Event | 2008-03-03 |
| Date Mfgr Received | 2008-03-03 |
| Device Manufacturer Date | 2005-02-28 |
| Date Added to Maude | 2009-01-27 |
| 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 | FERENC DAHNER |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY |
| Manufacturer Country | SW |
| Manufacturer Phone | 41519800 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX VOICE PROSTHESIS |
| Generic Name | VOICE PROSTHESIS |
| Product Code | ESE |
| Date Received | 2008-04-02 |
| Returned To Mfg | 2008-03-12 |
| Model Number | PROVOX |
| Catalog Number | REF 7202 |
| Lot Number | 0502004 |
| Device Expiration Date | 2010-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 HORBY SE-242 2 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-02 |