MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-26 for PARENT'S CHOICE DISPOSABLE NURSING PADS manufactured by Unk.
[78658013]
The reporter is experiencing issues with her nursing pads that were purchased from a (b)(6). She noticed the pads are leaving cotton residue around her nipple after use. Also when removing the pad from her breast, the adhering glue remains on her skin. She is worried that her child will ingest these materials while feeding. When removing the pad from its individual packaging it occasionally tears along the lining of the pad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070625 |
| MDR Report Key | 6669320 |
| Date Received | 2017-06-26 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-06-24 |
| Date Added to Maude | 2017-06-27 |
| 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 | PARENT'S CHOICE DISPOSABLE NURSING PADS |
| Generic Name | NURSING PAD |
| Product Code | NTX |
| Date Received | 2017-06-26 |
| 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 | 2017-06-26 |