MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for VANTG METAL EAR SYRINGE 4 V919-385 manufactured by Integra York, Pa Inc..
[34242866]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[34242867]
Customer initially reports via medwatch # (b)(4) that ear wax was being removed by ent physician when the patient was injured. The physician was irrigating the patient's ear when the end of the plunger flew off and struck the inner ear that caused bleeding, but did not damage the ear drum. Patient was treated in the moment with direct pressure to the site of bleeding and offered ear drops to moisten ear wax. Patient was seen two weeks later and the ear wax was removed manually. On 12/1/2015 customer reports physician thinks the device threads may have been damaged from use and so the part came off.
Patient Sequence No: 1, Text Type: D, B5
[38294426]
1/18/16 integra investigation completed. Manufacturing date unknown. Method: failure analysis, device history evaluation results: failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer. The ear syringe was not returned for further evaluation. Device history evaluation - dhr review was completed with all history available. Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report/nonconforming material report history. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: there are no applicable corrective action preventive action history. Health hazard evaluation history: none. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. The ear syringe was not returned for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00136 |
| MDR Report Key | 5320828 |
| Date Received | 2015-12-22 |
| Date of Report | 2015-11-30 |
| Date of Event | 2015-10-07 |
| Date Mfgr Received | 2016-01-18 |
| Date Added to Maude | 2015-12-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| 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 | 2015-12-22 |
| Catalog Number | V919-385 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-22 |