MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-17 for OAE PEDIATRIC FOAM EAR TIPS 203211 manufactured by Natus Medical Inc..
[93054264]
A total of 64 bags of the oae pediatric foam tips were received. Fourteen foam tips from lot n050217-05 were examined. Upon removal from the plastic packaging, the foam tips are still adequately glued to the inner tubing after a visual inspection. Testing was performed to confirm the alleged malfunction and the failure could not be confirmed. The customer was provided replacement foam tips. 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. Natus is investigating this issue through corrective actions at this time.
Patient Sequence No: 1, Text Type: N, H10
[93054265]
The customer reported to natus medical that the foam tips of the pediatric foam ear tips are separating from the inner plastic tubing. There has been no report of patient death, injury or delay in patient treatment. No environmental or safety concerns have also been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00925 |
| MDR Report Key | 7042459 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-17 |
| Date of Report | 2017-10-10 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2017-05-02 |
| Date Added to Maude | 2017-11-17 |
| 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 INC. |
| 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 | 2017-11-17 |
| Returned To Mfg | 2017-10-25 |
| Model Number | 203211 |
| Lot Number | N050217-05 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-17 |