MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-08-10 for HYDROGEL PADS 87123 manufactured by Medela, Inc..
[2867375]
The customer reported to customer service to find out what the hydrogel pads are made of, as she is allergic to glycerin, and they are very painful to use.
Patient Sequence No: 1, Text Type: D, B5
[10024799]
Multiple attempts to contact the customer between the period of (b)(4) 2012, to get additional complaint information, including medical treatment, if any, were unsuccessful. On (b)(4) 2012, a letter was sent to the customer as a final contact attempt. Based on the information in the original customer report, it was determined that the event was not did not require a medwatch filing. On (b)(4) 2012, the customer contacted medela in response to the letter she received. She indicated that her baby had latch issues which caused bleeding and scabbing on her nipples. For relief from the pain, she tried lansinoh gel pads, but had a reaction to them because they contain glycerin, a known allergy she has. She purchased medela's gel pads because she couldn't determine if they had glycerine in them or not. When she used the, she had a similar reaction - a red, burning sensation on her breasts where the gel pads made contact with the skin. She discontinued use of the gel pads the next day. A couple of days later, her nipples were infected, she sought medical treatment and was prescribed penicillin. The infection has resolved. Her baby has learned to latch and she is using nipple shields to help prevent a re-occurrence of the bleeding and scabbing. She agreed to return the unused gel pads for testing/analysis. 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 | 1419937-2012-00285 |
| MDR Report Key | 2696470 |
| Report Source | 04 |
| Date Received | 2012-08-10 |
| Date of Report | 2012-06-29 |
| Date of Event | 2012-06-29 |
| Date Mfgr Received | 2012-06-29 |
| Date Added to Maude | 2012-08-15 |
| 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 | 2012-08-10 |
| 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 | 2012-08-10 |