MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-04 for SOFTSHELL (UNKNOWN) manufactured by Medela Ag.
[178195642]
An email response was sent to the customer, requesting that she contact customer service via phone so that her issue could be appropriately be addressed. As of the date of this report, the customer has not done so. The customer was contacted by a complaint handler on multiple occasions, including via phone, 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).
Patient Sequence No: 1, Text Type: N, H10
[178195643]
On (b)(6) 2019, the customer emailed medela llc alleging that the soft shell nipple shields created a huge circle around her breast and caused a lump with excruciating pain. She further alleged that it had pushed her breast implant to the top of her breast, which caused a bacterial infection which necessitated two prescription treatments. Additionally, she indicated that she was disappointed and sad because of the money spent since her milk had dried up and she was left unable to breastfeed due to the pain the nipple shields had caused her.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2020-00007 |
| MDR Report Key | 9666214 |
| Report Source | CONSUMER |
| Date Received | 2020-02-04 |
| Date of Report | 2019-12-28 |
| Date Mfgr Received | 2019-12-28 |
| Date Added to Maude | 2020-02-04 |
| 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 AG |
| Manufacturer Street | LATTICHSTRASSE 4B |
| Manufacturer City | BAAR ZUG 6341 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFTSHELL (UNKNOWN) |
| Generic Name | PUMP, BREAST, POWERED |
| Product Code | HGX |
| Date Received | 2020-02-04 |
| Model Number | SOFTSHELL (UNKNOWN) |
| Catalog Number | SOFTSHELL (UNKNOWN) |
| 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 AG |
| Manufacturer Address | LATTICHSTRASSE 4B BAAR ZUG, 6341 SZ 6341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |