MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-28 for PNSA STARTER BP EN ES USA 101035077 manufactured by Medela Llc.
[181479834]
Customer service verified breast shield fit with the customer and determined that the 27mm breast shields fit better than the 24mm breast shields. The customer could not complete all troubleshooting steps and stated that she would call back when she was able to. She contacted customer service again the same day and asked if she could try a larger breast shield size before completing additional troubleshooting. The customer was sent 27mm personal fit flex breast shields. In additional follow up with a complaint handler on (b)(6) 2020, the customer indicated she had seen a doctor and was prescribed a topical ointment for a bump on her nipple, which was a result of her engorgement that had started a week before contacting medela. Additionally, she indicated that the 27mm personal fit flex breast shields were more comfortable, having made a difference in her pumping experience, and the engorgement was resolved. The complaint handler asked the customer if she would like to return her 24mm breast shields for testing/evaluation, but the customer refused. Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed). The instructions for use provides instructions for breast shield sizing, including reference to medelabreastshields. Com and referral to a lactation consultant for assistance in choosing the correct size breast shield.
Patient Sequence No: 1, Text Type: N, H10
[181479835]
On (b)(6) 2020, the customer alleged to medela llc that her pump in style breast pump had low suction and she was engorged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2020-00014 |
| MDR Report Key | 9770118 |
| Report Source | CONSUMER |
| Date Received | 2020-02-28 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4358316 |
| Manufacturer G1 | MEDELA LLC |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY, IL |
| Manufacturer Country | US |
| 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 | 2020-02-28 |
| Model Number | 101035077 |
| Catalog Number | 101035077 |
| Lot Number | NI |
| 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 LLC |
| Manufacturer Address | 1101 CORPORATE DRIVE MCHENRY, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |