MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-13 for DISPOSABLE NURSING PAD * NONE manufactured by Evenflo Co, Inc..
[16783217]
Complainant reports nursing pads impart something to the breast of the mother which causes the baby to gag and resist nursing. If she wipes breast first prior to nursing the infant readily accepts the nursing. Since discontinuing the use of the pads the mother has not observed the infant gaging or resisting nursing. The complainant reportedly put her tongue to the pad and noticed. A strong chemical taste.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001769 |
| MDR Report Key | 68447 |
| Date Received | 1997-02-13 |
| Date of Report | 1996-10-22 |
| Date Added to Maude | 1997-02-14 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE NURSING PAD |
| Generic Name | NURSING PAD |
| Product Code | HFS |
| Date Received | 1997-02-13 |
| Model Number | * |
| Catalog Number | NONE |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 68429 |
| Manufacturer | EVENFLO CO, INC. |
| Manufacturer Address | 1801 COMMERCE DR PIQUA OH 45356 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-13 |