MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-29 for OAE PEDIATRIC FOAM EAR TIPS 203211 manufactured by Natus Medical Incorporated.
[96112994]
Replacement parts were sent out to the customer. Several attempts were made to retrieved the suspected items too be returned. Natus will investigate this further once the customer has returned the items to natus.
Patient Sequence No: 1, Text Type: N, H10
[96112995]
Natus medical received a complaint on (b)(6) 2017. A representative calling on behave of the customer, reported that the customer was having issues with the tips. The following information was noted, "there is less stem/tubing and when you squeeze the foam to put on oae push into hear, you're actually pushing tubing through the foam so the tubing sticks into their ear. The customer confirmed there was no death/serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-01072 |
| MDR Report Key | 7155115 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-29 |
| Date of Report | 2017-11-30 |
| Date Mfgr Received | 2017-11-30 |
| Date Added to Maude | 2017-12-29 |
| 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 | MARC RIVAS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685142 |
| 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 |
| 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 | 2017-12-29 |
| Model Number | 203211 |
| Lot Number | NO32217-04 |
| Device Availability | N |
| 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 | 2017-12-29 |