MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-24 for SOUND BODY manufactured by Filo America.
[46187210]
Consumer stated that the cotton tips of the q-tip came off in his ear canal and he had to dig it out. He stated the warning stated that he should swab around the ear drum not to be used in the ear canal. He feels that the q-tip is misleading because it should be used to clean out the ear drums. Injury information: injury, level of care not known. Retailer: (b)(6). Retailer state: (b)(6). The product was damaged before the incident: no. The product was modified before the incident: no. Document number: (b)(4), report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062508 |
| MDR Report Key | 5684509 |
| Date Received | 2016-05-24 |
| Date of Report | 2016-05-10 |
| Date of Event | 2016-04-30 |
| Date Added to Maude | 2016-05-27 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | SOUND BODY |
| Generic Name | Q-TIPS |
| Product Code | KXF |
| Date Received | 2016-05-24 |
| Lot Number | 8723 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FILO AMERICA |
| Manufacturer Address | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-24 |