MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-04-03 for EXTENSIBLE TITANIUM PARTIAL PROSTHESIS PAP 07.64 manufactured by Audio Technologies Srl.
[4612152]
A distributor has reported an event that happened during an audio prosthesis, explanted from a patient. Here below the report from the distributor: "customer states they have explanted (b)(6) 2014 and found product to be broken. "
Patient Sequence No: 1, Text Type: D, B5
[11941844]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616949-2014-00001 |
| MDR Report Key | 3963687 |
| Report Source | 08 |
| Date Received | 2014-04-03 |
| Date of Report | 2014-03-28 |
| Date of Event | 2014-03-24 |
| Date Mfgr Received | 2014-03-26 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2014-08-05 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELENA TIRELLI |
| Manufacturer Street | VIA DELL' ARTIGIANATO, 8 |
| Manufacturer City | GOSSOLENGO, PC 29020 |
| Manufacturer Country | IT |
| Manufacturer Postal | 29020 |
| Manufacturer Phone | 523778864 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTENSIBLE TITANIUM PARTIAL PROSTHESIS |
| Generic Name | EXTENSIBLE PARTIAL PROSTHESIS |
| Product Code | ETB |
| Date Received | 2014-04-03 |
| Model Number | PAP 07.64 |
| Catalog Number | PAP 07.64 |
| Lot Number | 0212 |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AUDIO TECHNOLOGIES SRL |
| Manufacturer Address | VIA DELL'ARTIGIANATO, 8 GOSSOLENGO, PC 29020 IT 29020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-03 |