MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-22 for VANTAGE EAR IRRIGATION SYRINGE V919-385 ACV919-385 manufactured by Integra Inc.
[2825454]
During irrigation of pt's ear with syringe of warm water the end cap came off its threads and in the process tip was inserted into pt's ear canal, piercing her tympanic membrane. Syringe was nearly new and threads had failed. Dates of use: (b)(6) 2011. Diagnosis or reason for use: cerumen impacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025980 |
| MDR Report Key | 2634270 |
| Date Received | 2012-06-22 |
| Date of Report | 2012-03-20 |
| Date of Event | 2011-12-14 |
| Date Added to Maude | 2012-07-05 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANTAGE EAR IRRIGATION SYRINGE |
| Generic Name | SYRINGE EAR SYRINGE 4 OZ |
| Product Code | JYH |
| Date Received | 2012-06-22 |
| Model Number | V919-385 |
| Catalog Number | ACV919-385 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA INC |
| Manufacturer Address | YORK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-06-22 |