MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for UNILEVER Q-TIP 500 COUNT BOX 305215007005 manufactured by Unilever Us, Inc..
[144249627]
Submitter says that the product is no longer well made. Over the last two to three years the product is not of the same quality. Caller believes the company cuts corners to save money. Caller says that the cotton is not tightly wound onto the (b)(6) and could possibly come loose inside of your ear and force you to have to visit the emergency room to remove the cotton. Purchase date: (b)(6) 2019; this date is an estimate. Retailer: (b)(6). Retailer state: (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086364 |
| MDR Report Key | 8577922 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-02 |
| Date Added to Maude | 2019-05-03 |
| 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 | UNILEVER Q-TIP 500 COUNT BOX |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, NON STERILE |
| Product Code | KXF |
| Date Received | 2019-05-02 |
| Model Number | 305215007005 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNILEVER US, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |