MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for HUGGIES SIMPLY CLEAN FRESH SCENT manufactured by Kimberly-clark.
[38976005]
I was using a pack of huggies simply clean fresh scent baby wipes and i started noticing green spots on the wipes. I opened the plastic bag that they came in and the entire side of the wipes was covered in mold. The package was opened less than 24 hours ago. Diagnosis or reason for use: cleaning my daughter's diaper area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060408 |
| MDR Report Key | 5454915 |
| Date Received | 2016-02-19 |
| Date Added to Maude | 2016-02-23 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | HUGGIES SIMPLY CLEAN FRESH SCENT |
| Generic Name | BABY WIPES |
| Product Code | LDQ |
| Date Received | 2016-02-19 |
| Lot Number | M1531607X |
| Device Expiration Date | 2017-11-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-19 |