MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for GE 750W manufactured by Ge Healthcare Manufacturing Llc.
[136233980]
During the mri scan the patient complained about loud noise from his right ear. We checked on him and found the larger ear plug was in his ear almost all the way. I was able to put it in further and used the small fold-ble cushion to keep it in place and somewhat cover his ear at the same time. We finished the exam without further complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083801 |
| MDR Report Key | 8315352 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-02-04 |
| Date Added to Maude | 2019-02-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GE 750W |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2019-02-06 |
| Model Number | 750W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE MANUFACTURING LLC |
| Manufacturer Address | WAUKESHA WI US |
| Brand Name | EAR PLUGS |
| Generic Name | PROTECTOR, HEARING (INSERT) |
| Product Code | EWD |
| Date Received | 2019-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-06 |