MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2011-10-04 for VANTG METAL EAR SYRINGE 4 V919-385 manufactured by Integra, York - Imiltex.
[2283245]
Customer reported "the back threads of the syringe tip broke free and pushed into ear canal and ruptured ear drum during procedure". On (b)(6) 2011 the laboratory technician reported the patient was seen on (b)(6) 2011 in the facility and needed to have this ears syringed. The tip of the syringe pushed into the left ear canal and ruptured the patient's left ear drum. He did not require any surgical intervention and was seen and treated by an (ent) ear nose and throat physician. The laboratory technician stated the doctor's note noted the patient had a slight loss of hearing in his left ear.
Patient Sequence No: 1, Text Type: D, B5
[9357203]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00070 |
| MDR Report Key | 2282214 |
| Report Source | 05,06,08 |
| Date Received | 2011-10-04 |
| Date of Report | 2011-10-04 |
| Date of Event | 2011-09-02 |
| Date Mfgr Received | 2011-09-22 |
| Date Added to Maude | 2011-10-11 |
| 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 | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| 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 | 2011-10-04 |
| Catalog Number | V919-385 |
| Lot Number | 8157 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, YORK - IMILTEX |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-04 |