MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-04 for OAE ADULT FOAM EAR TIPS 203212 manufactured by Natus Medical Inc..
[94796853]
The customer was provided replacement foam tips. Natus was also sent adult foam tips for evaluation. Fourteen adult foam tips were tested, and six of the foam tips could easily separate from the tubing with a small amount of applied pressure. 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
[94796854]
The customer reported to natus medical that the foam is sliding of the inner plastic tubing of the foam ear tip assemblies. There has been no report of patient death or injury, but the customer has reported a delay in treatment and safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00993 |
| MDR Report Key | 7081397 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-04 |
| Date of Report | 2017-11-06 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2016-06-14 |
| Date Added to Maude | 2017-12-04 |
| 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 ADULT FOAM EAR TIPS |
| Generic Name | OAE ADULT FOAM EAR TIPS |
| Product Code | GWJ |
| Date Received | 2017-12-04 |
| Returned To Mfg | 2017-11-17 |
| Model Number | 203212 |
| Lot Number | N061416-04 |
| 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 | 2017-12-04 |