MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-24 for ASTEAME NIPPLE GUARD * AMD-NPLG-00004 manufactured by Asteame Medical Devices Inc..
[15858043]
Physician used the asteame nipple covers on the patient. When the patient came back for her follow up visit she had a fungal infection. Physician feels that they are too tight and are not giving enough breathing room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2758808 |
| MDR Report Key | 2758808 |
| Date Received | 2012-08-24 |
| Date of Report | 2012-08-24 |
| Date of Event | 2011-09-01 |
| Report Date | 2012-08-24 |
| Date Reported to FDA | 2012-08-24 |
| Date Added to Maude | 2012-09-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASTEAME NIPPLE GUARD |
| Generic Name | SHIELD, NIPPLE |
| Product Code | HFS |
| Date Received | 2012-08-24 |
| Model Number | * |
| Catalog Number | AMD-NPLG-00004 |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASTEAME MEDICAL DEVICES INC. |
| Manufacturer Address | 14375 SARATOGA AVENUE # 205 SARATOGA CA 95070598 US 95070 5988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-24 |