MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for MEDLINE REINER EAR SYRINGE MDS 4409710 NA manufactured by Medline Industries, Inc..
[130331121]
While flushing the right ear using the device, the top of the syringe popped off propelling the tip of the syringe deeper into the pt's ear canal causing pain and bleeding. Diagnosis or reason for use: ear wax impaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082072 |
| MDR Report Key | 8160302 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-10-24 |
| Date Added to Maude | 2018-12-13 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Brand Name | MEDLINE REINER EAR SYRINGE |
| Generic Name | SYRINGE, ENT |
| Product Code | KCP |
| Date Received | 2018-12-12 |
| Model Number | MDS 4409710 |
| Catalog Number | NA |
| Lot Number | 00081619 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |