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 SHELLS FOR INVERTED NIPPLES 80220 manufactured by Medela, Inc..
[2781311]
The customer contacted customer service to inquire about what the soft shells are made of, as she had developed a rash after using them.
Patient Sequence No: 1, Text Type: D, B5
[10109224]
The customer was advised that the soft shells are made of silicone. In follow up with the customer, she indicated that after using the soft shells for one day, she developed a rash that looked like little blisters which were extremely itchy. The rash was on both breast where the software shells made contact with her skin. She was prescribed a 2. 5% strength cortisone cream. She discontinued use of the soft shells and used the cortisone cream for a short time, both after which the rash and itching started to subside. She also indicated that she recently discovered that she has an adhesive allergy after a reaction to take that was used during her c-section. The customer confirmed that she would return the soft shells for testing/analysis; however, as of the date of this report, they have not been received. 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 | 1419937-2012-00244 |
| MDR Report Key | 2680650 |
| 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 SHELLS FOR INVERTED NIPPLES |
| Product Code | HFS |
| Date Received | 2012-08-01 |
| Model Number | 80220 |
| Catalog Number | 80220 |
| 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 | 2012-08-01 |