MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-04 for ADVANCED ANTI-BACTERIAL STRONG STRIPS, XL, LATEX FREE manufactured by Rite-aid.
[4317112]
Last week, pt had a needle puncture on her left thumb. The above mentioned band aid was applied to it. The next morning, while trying to pull it out, it came off with her skin. She started bleeding and was rushed to the er, where it was determined that she was having an allergic reaction. She called (b)(6) and asked for the active ingredients in the device and was told it was benzalkonium chloride 0. 1% but that she should note that the problem wasn't the active ingredient but the adhesive on the strip. The wound is now healing but is going to leave a scar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034810 |
| MDR Report Key | 3664705 |
| Date Received | 2014-03-04 |
| Date of Report | 2014-03-04 |
| Date of Event | 2014-02-18 |
| Date Added to Maude | 2014-03-07 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED ANTI-BACTERIAL STRONG STRIPS, XL, LATEX FREE |
| Generic Name | BAND-AID |
| Product Code | MXE |
| Date Received | 2014-03-04 |
| ID Number | UPC 1182257368 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RITE-AID |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-04 |