MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for Q-TIPS manufactured by Unk.
[131485634]
Caller is reporting that the q-tip package stated that it contained antimicrobial but "the" needs the company to label each tips individually that it contains antimicrobial because she does not know if the one she decides to use is pure cotton or not. Caller stated that she is highly allergic to antimicrobial products. Caller feels that these q-tips are a health hazard and should be reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082378 |
| MDR Report Key | 8186592 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-01 |
| Date Added to Maude | 2018-12-20 |
| 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 | Q-TIPS |
| Generic Name | APPLICATOR, ABSORBENT, TIPPED, NON-STERILE |
| Product Code | KXF |
| Date Received | 2018-12-19 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |