MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-07-14 for PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE/BREASTSHIELDS 8107175/87075/57063 manufactured by Medela, Inc..
[4640989]
The customer reported to customer service that the breastshields she was using with her pump in style breast pump had caused an allergic reaction that required medical attention.
Patient Sequence No: 1, Text Type: D, B5
[12151487]
The customer reported that she has a rash on her areola that was infected. Her doctor put her on mystatin ointment, neosprin, hydrocortisone cream 1%, desonide ointment 0. 5%, cephalexin 50 mg 3x daily. 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. This issue is currently being investigated (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2014-00553 |
| MDR Report Key | 3950973 |
| Report Source | 04 |
| Date Received | 2014-07-14 |
| Date of Report | 2014-07-02 |
| Date of Event | 2014-05-02 |
| Date Facility Aware | 2014-07-02 |
| Report Date | 2014-07-02 |
| Date Mfgr Received | 2014-07-02 |
| Date Added to Maude | 2014-07-23 |
| 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 | PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE/BREASTSHIELDS |
| Product Code | HFS |
| Date Received | 2014-07-14 |
| Model Number | 8107175/87075/57063 |
| Catalog Number | 8107175/87075/57063 |
| Lot Number | NA |
| 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 | 2014-07-14 |