MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for REINER EAR SYRINGE MDS 4409710 manufactured by Medline Industries, Inc..
[130338679]
Ear irrigation done for bilateral cerumen impaction. Device came apart during procedure, tip went forward - caused abrasion of the ear canal with pain. She had minor bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082071 |
| MDR Report Key | 8160301 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-10-02 |
| 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 |
| 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 | REINER EAR SYRINGE |
| Generic Name | SYRINGE, ENT |
| Product Code | KCP |
| Date Received | 2018-12-12 |
| Model Number | MDS 4409710 |
| 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 |