MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-10-21 for HARMONY RETAIL 67186 manufactured by Medela Inc..
[28907804]
A replacement pump was sent to the customer. The product involved in the complaint was not returned for evaluation/investigation at this time. Therefore, no conclusions can be made as to the cause of the event. It can not be definitively concluded that the pump caused or contributed to the customer's thrush. Reported issues of thrush are under investigation in (b)(4). Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.
Patient Sequence No: 1, Text Type: N, H10
[28907865]
The customer reported to customer service that she has mold on her harmony pump, and states she cleans it after every use. The customer also reported that she and the baby have thrush and have been prescribed an antibiotic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2015-00309 |
| MDR Report Key | 5167210 |
| Report Source | CONSUMER |
| Date Received | 2015-10-21 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-10-15 |
| Date Added to Maude | 2015-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | DONALD ALEXANDER |
| Manufacturer Street | 1101 CORPORATE DR. |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer Phone | 8155782270 |
| Manufacturer G1 | MEDELA INC. |
| Manufacturer Street | 1101 CORPORATE DR. |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARMONY RETAIL |
| Generic Name | HGY |
| Product Code | HGY |
| Date Received | 2015-10-21 |
| Model Number | 67186 |
| Catalog Number | 67186 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA INC. |
| Manufacturer Address | 1101 CORPORATE DR. MCHENRY IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-21 |