MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-28 for PNSA STARTER BP EN ES USA 101035077 manufactured by Medela Llc.
[176751185]
The customer was sent replacement 21mm personal fit breast shields so that she could return them to a retail location for a refund and her original breast shields were requested to be returned for testing/evaluation. The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report. Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed). Reported issues of rash were investigated under (b)(4), which determined the root cause to be potential for the product, after it is opened, to come in contact with environmental allergens, lotions or creams, and cleaning solutions that may cause an allergic reaction or irritation. Such root cause is not a product malfunction or a deficiency in information available to the user.
Patient Sequence No: 1, Text Type: N, H10
[176751186]
On (b)(6) 2020, the customer alleged to medela llc that the 21mm personal fit breast shields she was using with her pump in style breast pump had caused her to develop a rash. She additionally alleged that she had seen a dermatologist and her obgyn doctor, who advised her that it was an allergic reaction to polypropylene and she was prescribed a steroid as treatment for two weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2020-00005 |
| MDR Report Key | 9639563 |
| Report Source | CONSUMER |
| Date Received | 2020-01-28 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAN KLOIBER |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer Phone | 8004358316 |
| Manufacturer G1 | MEDELA LLC |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| 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 | PNSA STARTER BP EN ES USA |
| Generic Name | PUMP, BREAST, POWERED |
| Product Code | HGX |
| Date Received | 2020-01-28 |
| Model Number | 101035077 |
| Catalog Number | 101035077 |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA LLC |
| Manufacturer Address | 1101 CORPORATE DRIVE MCHENRY IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-28 |