MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for NIPPLE SHIELD (UNKNOWN) manufactured by Medela Ag.
[140119433]
The customer was provided tips and nipple shield sizing information via email and was urged to contact customer service so that her issue could appropriately be addressed. In follow up with a complaint handler on 03/01/2019, the customer indicated that she started out with a smaller nipple shield when her baby was born and went up to 24mm as he got bigger, but it was too small and caused pinching as he breastfed, which led to cracking of her nipples. She indicated that she was between the 27mm and 30mm sizes. The customer alleged that due to the cracks, she developed an infection which she picked up in the hospital where her premature infant was hospitalized, for which she was prescribed medication. She indicated that she was no longer experiencing the issue because she was no longer using the nipple shields. In follow up with a medela clinician on 03/10/2019, the customer was provided with information regarding exclusive pumping and weaning off of the nipple shields. The customer indicated that she found a competitor product that is a 28mm that works for her. The clinician arranged to send the customer 27mm medela flex breast shields for her to try for breast pumping. Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Patient Sequence No: 1, Text Type: N, H10
[140119434]
On (b)(6) 2019, the customer emailed medela llc, indicating that it would be "nice" if there were larger size options for the nipple shields. The customer alleged that the nipple shields were too small for her and caused her nipples to crack. Because of the cracking, she had to use the soft shells for sore nipples, and even those were too small.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2019-00051 |
| MDR Report Key | 8457594 |
| Date Received | 2019-03-27 |
| Date of Event | 2019-02-17 |
| Date Mfgr Received | 2019-05-28 |
| Date Added to Maude | 2019-03-27 |
| 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 | 0 |
| Brand Name | NIPPLE SHIELD (UNKNOWN) |
| Generic Name | SHIELD, NIPPLE |
| Product Code | HFS |
| Date Received | 2019-03-27 |
| Model Number | NIPPLE SHIELD (UNKNOWN) |
| Catalog Number | NIPPLE SHIELD (UNKNOWN) |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA AG |
| Manufacturer Address | LATTICHSTRASSE 4B BAAR ZUG 6341, SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-27 |