MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-19 for ULTRA SOFT CLEANSING WIPES manufactured by Cvs Pharmacy Inc..
[41172316]
I used a product that caused a red rash. I am concerned because use this product on babies. Babies may get rashes, and people may not know that it would come from a baby product. It is called cvs pharmacy ultra soft cleansing wipes with aloe and vitamin e. The 100 percent plant based fibers it comes in a three pack called value pack. I bought another three pack that was the same product. The packages had stamps: (b)(4). The package i used and the other two packs in the value pack did not have these stamps anywhere on the packages. The product also had a small number: (b)(4). It is labeled with the following: cvs pharmacy inc. : (b)(4). I previously have not had problems with cvs products. Reason for use: i use it for cleansing.
Patient Sequence No: 1, Text Type: D, B5
[42286963]
Follow up on previous report. Product submit/reported to (b)(6) pharmacy where purchased. Previous report stated: i used a product that caused a red rash. It is called (b)(6) pharmacy ultra soft cleansing wipes with aloe and vitamin e. The 100 percent plant based fibers it comes in a three pack called value pack. I bought another three pack that was the same product. The packages had stamps: (b)(4). The package i used and the other two packs in the value pack did not have these stamps anywhere on the packages. The product also had a small number: (b)(4). It is labeled with the following: (b)(4). Reason for use: i use it for cleansing. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061207 |
| MDR Report Key | 5522232 |
| Date Received | 2016-03-19 |
| Date of Report | 2016-03-16 |
| Date of Event | 2016-03-19 |
| Date Added to Maude | 2016-03-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| 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 | 3 |
| Brand Name | ULTRA SOFT CLEANSING WIPES |
| Generic Name | ULTRA SOFT CLEANSING WIPES |
| Product Code | NSB |
| Date Received | 2016-03-19 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CVS PHARMACY INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-19 |