MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-07-02 for BREASTSHIELD, PERSONALFIT STANDARD 8107084 / 87073 manufactured by Medela, Inc.
[18056703]
The customer reported to customer service that her breast shields did not fit and resulted in mastitis.
Patient Sequence No: 1, Text Type: D, B5
[18409646]
A larger set of breast shields have been sent to the customer. In a f/u with customer, the customer stated that she was diagnosed with mastitis by a nurse practioner with the women's health care specialist. She was prescribed keflex antibiotic to treat the issue. The mastitis began on sunday (b)(6) 2013, due to the breastshields she was using were too small. As of (b)(6) 2013, she was fitted for the correct size breastshields, the fever was gone, but she was still feeling a decreased amount of pain. On (b)(6) 2013, the clinical department spoke with the customer and reported that the customer purchased larger breastshield and she feels that it was a good fit. She was still taking antibiotics, but is feeling much better and her issues are resolving. Clinical department found no indication of an adverse event effect or need for clinical f/u. "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 and wamback, 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. Customer sought medical care and is being treated with antibiotics and is now recovering. Reported issues of mastitis are under investigation in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2013-00343 |
| MDR Report Key | 3207251 |
| Report Source | 04 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-06-05 |
| Date of Event | 2013-06-05 |
| Date Facility Aware | 2013-06-05 |
| Report Date | 2013-06-05 |
| Date Mfgr Received | 2013-06-05 |
| Date Added to Maude | 2013-07-08 |
| 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 DRIVE |
| 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 | BREASTSHIELD, PERSONALFIT STANDARD |
| Product Code | HFS |
| Date Received | 2013-07-02 |
| Model Number | 8107084 / 87073 |
| Catalog Number | 8107084 / 87073 |
| 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 | 2013-07-02 |