MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-07 for PERSONAL FIT BREASTSHIELDS 8107175 & 8107176 manufactured by Medela, Inc..
[16223261]
The customer called customer service to report that she has developed a repeated infection in her breasts. Her doctor believes that it is an allergy to the breastshields that are manufactured by medela.
Patient Sequence No: 1, Text Type: D, B5
[16286558]
The customer reported that she had developed an infection in her breasts. Her doctor has prescribed antibiotics for the infection. The product involved in the compliant was not returned for evaluation/investigation at this time. Therefore, no conclusions can be made as to the cause of the event. A clinician from medela is going to contact the customer to follow up. Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up will be filed that time. 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. " riordoan & wambach, 4th ed. P. 294: breastfeeding and human lactation. Mastitis requires prompt medical attention for the mother for pain relieve and prescription antibiotics to avoid progression to overwhelming sepsis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2014-00169 |
| MDR Report Key | 3642030 |
| Report Source | 04 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-02-04 |
| Date of Event | 2014-02-04 |
| Date Facility Aware | 2014-02-04 |
| Report Date | 2014-02-04 |
| Date Mfgr Received | 2014-02-04 |
| Date Added to Maude | 2014-02-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DON ALEXANDER |
| Manufacturer Street | 1101 CORPORATE DR. |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer Phone | 8004358316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONAL FIT BREASTSHIELDS |
| Product Code | HFS |
| Date Received | 2014-02-07 |
| Model Number | 8107175 & 8107176 |
| Catalog Number | 8107175 & 8107176 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA, INC. |
| Manufacturer Address | MCHENRY IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-07 |