MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-14 for * PAPARELLA-TYPE VENT TUBE 1.27MM SILICONE 240046 manufactured by Gyrus Acmi, Inc..
[4163843]
Implantable device; intended to be inserted into and remain in patient: device found to be defective during routine inspection prior to insertion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3590714 |
| MDR Report Key | 3590714 |
| Date Received | 2014-01-14 |
| Date of Report | 2014-01-14 |
| Date of Event | 2014-01-03 |
| Report Date | 2014-01-14 |
| Date Reported to FDA | 2014-01-14 |
| Date Reported to Mfgr | 2014-01-24 |
| Date Added to Maude | 2014-01-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | * |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2014-01-14 |
| Model Number | PAPARELLA-TYPE VENT TUBE 1.27MM SILICONE |
| Catalog Number | 240046 |
| Lot Number | JC482641 |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-14 |