MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for Q-TIPS manufactured by Unk.
[63224033]
Caller is reporting that the cotton swabs are broken at the ends and if a user is not paying attention it can get dislodged in their ear. She stated that she was almost halfway through the package when she noticed that they had a problem. On (b)(6) caller stated that she contacted the manufacturer through email but she did not receive a response. Caller feels that these cotton swabs are a safety hazard and should be reported. Injury information: incident, no injury. Product category: personal care. Retailer: (b)(6). Retailer state: (b)(6). I still have the product in my possession: yes. Have you contacted the manufacturer: yes. If not, do you plan to contact them: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066868 |
| MDR Report Key | 6199361 |
| Date Received | 2016-12-20 |
| Date of Report | 2016-12-07 |
| Date of Event | 2016-12-04 |
| Date Added to Maude | 2016-12-22 |
| 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 |
| 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 | Q-TIPS |
| Generic Name | COTTON SWABS |
| Product Code | KXF |
| Date Received | 2016-12-20 |
| Device Availability | I |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-20 |