MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-21 for PHILIPS SLIMLINE HEAD PHONES 104885 * manufactured by Philips.
[16744397]
As technician was in the process of putting the acoustic headphones on the patient, the headphones snapped in two pieces right in the patient's face. One of the broken pieces touched the area just to the left of her left eye. The skin was not broken but the patient was visibly upset. ====================== health professional's impression======================the technician stated that this happens frequently and is probably due to cheap plastic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1770665 |
| MDR Report Key | 1770665 |
| Date Received | 2010-07-21 |
| Date of Report | 2010-07-21 |
| Date of Event | 2010-07-19 |
| Report Date | 2010-07-21 |
| Date Reported to FDA | 2010-07-21 |
| Date Added to Maude | 2010-07-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS SLIMLINE HEAD PHONES |
| Generic Name | ACOUSTIC HEAD PHONES |
| Product Code | EWE |
| Date Received | 2010-07-21 |
| Model Number | 104885 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810109 US 01810 1099 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-21 |