MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-10-28 for HS DSP EAR CUR LG SPOON 9004672 manufactured by Integra York, Pa Inc..
[3945772]
Customer initially reports patients were scratched in the ear canal. Drew a little blood but no hospitalization was needed. On (b)(6) 2013, doctor reports she was using device to remove ear wax for which it was intended, causing cuts in the ear canal mucosa at a lightest touch, when it is introduced to the ear canal. It caused ear canal bleeding in the 3 patients right away, before doctor was even able to get any of the wax out. No harm beyond the scratch, treated with antibiotic drops x bid for 3 days.
Patient Sequence No: 1, Text Type: D, B5
[11373502]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2013-00063 |
| MDR Report Key | 3445214 |
| Report Source | 08 |
| Date Received | 2013-10-28 |
| Date of Report | 2013-10-28 |
| Date Mfgr Received | 2013-10-02 |
| Date Added to Maude | 2013-11-05 |
| 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 DRIVE |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HS DSP EAR CUR LG SPOON |
| Generic Name | M11-ENT |
| Product Code | JZE |
| Date Received | 2013-10-28 |
| Catalog Number | 9004672 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-28 |