MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for BLOOM BABY WIPES manufactured by Hangzhou Special Nonwovens Co. Ltd..
[130466644]
I opened a package of bloom baby wipes and they were covered in black mold. I placed a complaint online since i purchased them on (b)(6). I also called the manufacturer us nonwovens and filed a complaint. No one has called back to get information from me to investigate. I still have the package with codes and product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082093 |
| MDR Report Key | 8160585 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-12-03 |
| Date Added to Maude | 2018-12-13 |
| 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 | BLOOM BABY WIPES |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2018-12-12 |
| Lot Number | 111488 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANGZHOU SPECIAL NONWOVENS CO. LTD. |
| Manufacturer Address | 602 ROCKWOOD RD. WILMINGTON DE 19802 US 19802 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |