MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-10 for OAE ADULT FOAM EAR TIPS 203212 manufactured by Natus Medical Inc..
[108288002]
The customer was provided replacement foam tips, and product returns have been requested. Natus instructions include selecting the appropriate size ear tip for the patient, as well as instructions not to pinch the foam while attaching the ear tip onto the nozzle and to use larger size foam tips for insertion into the ear canal when necessary. Instructions also state not to 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
[108288003]
The customer reported to natus medical that the foam tips of the adult foam ear tips are sliding off of 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 | 3018859-2018-00125 |
| MDR Report Key | 7505193 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-10 |
| Date of Report | 2018-04-13 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2017-09-05 |
| Date Added to Maude | 2018-05-10 |
| 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 | 2062685173 |
| 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 | 2018-05-10 |
| Model Number | 203212 |
| Lot Number | N090517-01 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-05-10 |