MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-07-16 for VANTG METAL EAR SYRINGE 4 V919-385 manufactured by Integra York, Pa Inc..
[2816552]
The customer initially reports that during irrigation of pt's ear with water, the end cap came off its threads. In the process, tip was inserted into pt's ear canal piercing her tympanic membrane. Syringe was nearly new and threads had failed. On (b)(6) 2012, the customer was reluctant to provide any further info and reports that the device will not be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[10075394]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00062 |
| MDR Report Key | 2662539 |
| Report Source | 99 |
| Date Received | 2012-07-16 |
| Date of Report | 2012-07-13 |
| Date Mfgr Received | 2012-06-28 |
| Date Added to Maude | 2012-11-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANTG METAL EAR SYRINGE 4 |
| Generic Name | M11 - ENT |
| Product Code | KCP |
| Date Received | 2012-07-16 |
| Catalog Number | V919-385 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-16 |