MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-06-20 for HARMONY MANUAL BREASTPUMP 67186 manufactured by Medela, Ag.
[47772436]
A replacement pump was sent to the customer. 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. Though the product has been received, it has not yet been tested/analyzed by quality engineering. Therefore, no conclusions can be made as to the cause of the event. Should additional information 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
[47772437]
The customer reported to customer service on 05/23/2016, that her harmony breast pump had low suction and she developed mastitis and was prescribed an antibiotic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2016-00152 |
| MDR Report Key | 5736666 |
| Report Source | CONSUMER |
| Date Received | 2016-06-20 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-05-23 |
| Date Facility Aware | 2016-05-23 |
| Date Mfgr Received | 2016-05-23 |
| Date Added to Maude | 2016-06-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT SOKOLOWKI |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer Phone | 8004358316 |
| Manufacturer G1 | MEDELA, AG |
| Manufacturer Street | LATTICHSTRASSE 4B |
| Manufacturer City | BARR ZUG 6341 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARMONY MANUAL BREASTPUMP |
| Generic Name | PUMP, BREAST, NON-POWERED |
| Product Code | HGY |
| Date Received | 2016-06-20 |
| Returned To Mfg | 2016-06-15 |
| Model Number | 67186 |
| Catalog Number | 67186 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA, AG |
| Manufacturer Address | LATTICHSTRASSE 4B BAAR ZUG 6341 SZ 6341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-20 |