MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-01 for HARMONY RETAIL 67186 manufactured by Medela Inc..
[27339704]
A medela clinician followed up with the customer on (b)(4) 2015. The customer stated that she was diagnosed with mastitis and was prescribed clindamycin by her physician, and it is now resolved. The customer also stated while she took clindamycin she was putting her baby on breast more often to treat mastitis. It cannot be definitively concluded that the pump caused or contributed to the customer's mastitis. Reported issues of mastitis are under investigation in (b)(4). Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant. The risk of mastitis is higher among women who have breastfed previously, especially those with a history or mastitis. " riordan & wambach, 4th ed. P. 294: breastfeeding and human lactation. Mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis. 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. 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
[27339705]
The customer emailed the customer service department that she was using the harmony manual pump and became engorged. A medela clinician followed up with the customer on (b)(4) 2015, and the customer stated that she was diagnosed with mastitis, was prescribed clindamycin by her physician, and it is now resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2015-00292 |
| MDR Report Key | 5119715 |
| Date Received | 2015-10-01 |
| Date of Report | 2015-09-13 |
| Date of Event | 2015-09-13 |
| Date Mfgr Received | 2015-09-13 |
| Date Added to Maude | 2015-10-01 |
| 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 | 0 |
| Brand Name | HARMONY RETAIL |
| Generic Name | HGY |
| Product Code | HGY |
| Date Received | 2015-10-01 |
| 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 | 2015-10-01 |