MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-07-08 for BREASTSHIELD, PERSONALFIT STANDARD 8107084 manufactured by Medela Inc..
[22244497]
The customer e-mailed customer service on (b)(6) 2015 stating she was having a severe allergic reaction ever since she started pumping and believed that she was allergic to the plastic flanges. During follow up with a medela clinician on (b)(6) 2015, the customer stated that she had been diagnosed with thrush, but diflucan and nystatin for 3 weeks did not resolve the rash. The customer's doctor referred her to a dermatologist, and she was diagnosed with contact dermatitis. She used cream which did not help. A biopsy was conducted which ruled out yeast. The customer's doctor thinks the rash is a possible reaction to some material in the plastic of the breastshields. The customer states the shape and size of the rash is exactly that of the breastshields. She had allergy testing performed, which resulted in only an allergy to gold. The customer tried softfit breastshields and had same reaction/no improvement. She has ordered a limerick pj pump but hasn't received it yet. The customer states she now has an infection around her nipples. She also stated she's using a spectra pump hacked with medela parts. The customer was informed that medela parts are warranted to work appropriately and within suction level parameters on medela pumps only.
Patient Sequence No: 1, Text Type: D, B5
[22349271]
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. It cannot be definitively concluded that the breastshields caused or contributed to the customer's rash.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2015-00222 |
| MDR Report Key | 4900896 |
| Report Source | 04 |
| Date Received | 2015-07-08 |
| Date of Report | 2015-07-08 |
| Date of Event | 2015-06-11 |
| Date Added to Maude | 2015-07-09 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONALD ALEXANDER |
| Manufacturer Street | 1101 CORPORATE DR. |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer Phone | 8155782270 |
| Manufacturer G1 | MEDELA INC. |
| Manufacturer Street | 1101 CORPORATE DR. |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREASTSHIELD, PERSONALFIT STANDARD |
| Generic Name | OHH |
| Product Code | OHH |
| Date Received | 2015-07-08 |
| Model Number | 8107084 |
| Catalog Number | 8107084 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA INC. |
| Manufacturer Address | 1101 CORPORATE DR. MCHENRY IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-08 |