MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-27 for VANTAGE METAL EAR SYRINGE V919?385 manufactured by Integra Lifesciences Corporation.
[32202157]
Patient Sequence No: 1, Text Type: N, H10
[32202158]
An ent physician was irrigating the patient's ear when the end of the plunger flew off and struck the inner ear. This caused bleeding, but did not damage her ear drum (tm).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5252824 |
| MDR Report Key | 5252824 |
| Date Received | 2015-11-27 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-10-07 |
| Report Date | 2015-11-24 |
| Date Reported to FDA | 2015-11-24 |
| Date Reported to Mfgr | 2015-11-24 |
| Date Added to Maude | 2015-11-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANTAGE METAL EAR SYRINGE |
| Generic Name | EXCAVATOR, EAR |
| Product Code | JYH |
| Date Received | 2015-11-27 |
| Catalog Number | V919?385 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-27 |