MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-28 for OAE PEDIATRIC FOAM EAR TIPS 203211 manufactured by Natus Medical Incorporated.
[93562008]
A replacement part was sent, resolving customer issue. Natus has requested the affected lot containing the foam tips for further investigation of this complaint. Natus instructions include selecting the appropriate size ear tip for the patient, as well as instructions regarding using larger size foam tips for insertion into the ear canal. Supplemental report will be submitted as needed.
Patient Sequence No: 1, Text Type: N, H10
[93562009]
Natus medical received a complaint on (b)(6) 2017. That their oae pediatric foam tip that have foam that is seperating from the tube before insertion into the ear. The customer confirmed that there was no death/serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00970 |
| MDR Report Key | 7065429 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-28 |
| Date of Report | 2017-11-01 |
| Date Mfgr Received | 2018-08-01 |
| Date Added to Maude | 2017-11-28 |
| 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 | JIM FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 5613065818 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OAE PEDIATRIC FOAM EAR TIPS |
| Generic Name | OAE PEDIATRIC FOAM EAR TIPS |
| Product Code | GWJ |
| Date Received | 2017-11-28 |
| Model Number | 203211 |
| Lot Number | N091616-02 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-28 |