MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-04-10 for HYDROGEL PADS 87123 manufactured by Medela, Inc..
[2601844]
The customer reported to customer service that she applied the hydrogel pads on saturday ((b)(6) 2012) and removed them the following day to find that her nipples looked as if they were burned. She found it painful and uncomfortable. She visited her doctor who advised her to "let it dry up" and did not prescribe medication. She wanted to understand why it happened and called customer service to ask what the ingredients are for the hydrogel pads. While on the call, the customer was on her way to visit a second doctor.
Patient Sequence No: 1, Text Type: D, B5
[9800272]
Attempts to follow up with the customer to get additional complaint information, including the results of the second doctor visit, and to get the product back, were unsuccessful other than a voice message left by the customer's husband stating "we are not sure how we are going to proceed. " the customer appears to have experienced an allergic reaction to the gel pads. Should additional information resulting in new, changed, or corrected information, a follow up report will be filed. We will monitor complaints for similar issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2012-00060 |
| MDR Report Key | 2536103 |
| Report Source | 04 |
| Date Received | 2012-04-10 |
| Date of Report | 2012-03-14 |
| Date of Event | 2012-03-10 |
| Date Mfgr Received | 2012-03-14 |
| Date Added to Maude | 2012-04-17 |
| 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 | HYDROGEL PADS |
| Product Code | NTC |
| Date Received | 2012-04-10 |
| Model Number | 87123 |
| Catalog Number | 87123 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA, INC. |
| Manufacturer Address | MCHENRY IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-10 |