MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-06 for PERSONALL FIT BREAST SHIELDS 8107074-87072 7107074-87072 manufactured by Medela, Inc..
[3836207]
The customer reported to customer svc that the size 24 mm breast shields seemed not to fit correctly causing pain which reduced milk supply causing mastitis.
Patient Sequence No: 1, Text Type: D, B5
[11009824]
In follow up with the customer on (b)(4) 2013 with a medela clinician, the customer informed the clinician that earlier she had experienced mastitis when using the breast shields and her doctor teated her with antibiotics. She responded well and is now recovered. Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant. The risk of mastitis is higher amount women who have breastfed previously, especially those with a history of mastitis. " riordan & wambach, 4th ed. P. 294. 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). The original product will not be returned, no physical evaluation will be completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2013-00386 |
| MDR Report Key | 3291995 |
| Report Source | 05 |
| Date Received | 2013-08-06 |
| Date of Report | 2013-07-09 |
| Date of Event | 2013-07-04 |
| Date Facility Aware | 2013-07-04 |
| Report Date | 2013-07-09 |
| Date Mfgr Received | 2013-07-04 |
| Date Added to Maude | 2013-08-19 |
| 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 60051 |
| Manufacturer Country | US |
| Manufacturer Postal | 60051 |
| Manufacturer Phone | 8004358316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONALL FIT BREAST SHIELDS |
| Product Code | HFS |
| Date Received | 2013-08-06 |
| Model Number | 8107074-87072 |
| Catalog Number | 7107074-87072 |
| 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 | 2013-08-06 |