MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-02 for 100 PERCENT PURE COTTON - DOUBLE-TIPPED manufactured by Greenbrier International Inc..
[38132343]
Device: 100 percent pure cotton, 350 count. Double tipped. The cotton on both ends of the plastic cotton swab, came apart and blocked in my ears from 5 swabs. Please open a formal investigation into my complaint. Please inform me of any accompanying sanctions and other equitable actions taken against the (b)(6) company and its distributors. I have enclosed identifiers from the box of cotton swabs and 10 swabs. Please forward my complaint to all federal and state regulatory agencies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060123 |
| MDR Report Key | 5431227 |
| Date Received | 2016-02-02 |
| Date of Report | 2016-01-07 |
| Date Added to Maude | 2016-02-11 |
| 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 |
| 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 | 100 PERCENT PURE COTTON - DOUBLE-TIPPED |
| Generic Name | 100 PERCENT PURE COTTON - DOUBLE-TIPPED - 350 COUNT |
| Product Code | KXF |
| Date Received | 2016-02-02 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREENBRIER INTERNATIONAL INC. |
| Manufacturer Address | 500 VOLVO PKWY. CHESAPEAKE VA 23320 US 23320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-02 |