MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-13 for OAE PEDIATRIC FOAM TIP 203211 manufactured by Natus Medical Incorporated.
[105663115]
Return of the defective oae pediatric foam tips was requested by natus, but they had already been discarded by the user. The complainant was provided replacement oae pediatric foam tips. Instructions for use provided with hearing devices compatible with oae pediatric foam tips state to not pinch the foam while attaching the ear tip onto the nozzle. For removing the foam ear tips, instructions state to not pull on the foam when removing the foam ear tips and caution that users may end up pulling the foam off the clear tube while the tube remains on the nozzle. Users are also instructed to remove, discard and replace probe tips before each test. Natus is investigating this issue through corrective actions at this time.
Patient Sequence No: 1, Text Type: N, H10
[105663116]
Natus received a report that the entire portion of foam separated from the plastic tubing. The report concerned two oae pediatric foam tips from the same lot number. There was no report of death, serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00114 |
| MDR Report Key | 7429548 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-15 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2017-03-22 |
| Date Added to Maude | 2018-04-13 |
| 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 | JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| 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 TIP |
| Generic Name | OAE PEDIATRIC FOAM TIP |
| Product Code | GWJ |
| Date Received | 2018-04-13 |
| Model Number | 203211 |
| Lot Number | N032217-04 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2018-04-13 |