MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-21 for TITANIUM ADJUSTABLE PARTIAL UNK PAP 07.64 manufactured by Invotec International Inc.
[17262788]
During surgery, the item was located and was found to be broken before being removed from the patient. Item is an audio tech partial ossicular prosthesis. Patient with chronic suppurative otitis media with cholesteatoma. She was admitted after the above listed procedure due to nausea and difficulty controlling pain with oral pain medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3716265 |
| MDR Report Key | 3716265 |
| Date Received | 2014-03-21 |
| Date of Report | 2014-03-21 |
| Date of Event | 2014-01-08 |
| Report Date | 2014-03-21 |
| Date Reported to FDA | 2014-03-21 |
| Date Reported to Mfgr | 2014-04-01 |
| Date Added to Maude | 2014-04-01 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | TITANIUM ADJUSTABLE PARTIAL |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2014-03-21 |
| Model Number | UNK |
| Catalog Number | PAP 07.64 |
| Lot Number | 0212 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVOTEC INTERNATIONAL INC |
| Manufacturer Address | 6833 PHILLIPS INDUSTRIAL BLVD JACKSONVILLE FL 32256 US 32256 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-21 |