MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-08-01 for SOFT SHELL FOR INVERTED NIPPLES 80210S manufactured by Medela, Inc..
[2732458]
The customer contacted customer service to inquire about what the soft shells are made of, as she had developed an allergic reaction to them. She started using the soft shells on (b)(6) 2012 and stopped using them on (b)(6) 2012. She broke out in hives on her stomach, face, and arms ("it's everywhere"). It started with two perfect circles on her breasts the size of the shells. She visited her doctor on (b)(6) 2012 and was given a steroid injection and a prescription for oral steroids (prednisone 200mg x 10 days) and a cream (name unk).
Patient Sequence No: 1, Text Type: D, B5
[10085666]
The customer was advised that the soft shells are made of silicone. Attempts to contact the customer to get additional complaint info and to get the product back, including a final attempt by letter, were unsuccessful. The customer appears to have experienced an allergic reaction to the soft shells. Should additional info or the product be received, resulting in new, changed, or corrected info, a follow up report will be filed. We will monitor complaints for similar issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2012-00245 |
| MDR Report Key | 2680634 |
| Report Source | 04 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-07-06 |
| Date of Event | 2012-07-06 |
| Date Mfgr Received | 2012-07-06 |
| Date Added to Maude | 2012-08-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DON ALEXANDER |
| Manufacturer Street | 1101 CORPORATE DR. |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer Phone | 8004358316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT SHELL FOR INVERTED NIPPLES |
| Product Code | HFS |
| Date Received | 2012-08-01 |
| Model Number | 80210S |
| Catalog Number | 80210S |
| 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, INC. |
| Manufacturer Address | MCHENRY IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-01 |