MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-10-29 for HYDROGEL PADS UNK manufactured by Medela, Inc.
[1669466]
The customer reported that, when using the lanolin cream, she felt burning and pain as soon as the baby latches on. She said it does go away, but it is painful.
Patient Sequence No: 1, Text Type: D, B5
[8896340]
In additional follow-up, the customer stated she was using the lanolin cream in conjunction with breastfeeding. However, the cream caused a burning sensation which created pain when the baby latched on. She stopped using the cream, stopped breast feeding, and turned to pumping exclusively (with a non-medela pump). The manufacturer representative who took the original call sent the customer hydrogel pads to help with the pain. According to the customer, the pads created a small, white pus-filled boil on her nipple (she described it as being like a white head and a "little white mark"), which was painful. She stopped using the hydrogel pads and consulted a physician, who prescribed an antibiotic (keflex, taken orally 4x a day for 7 days) over the phone, based on her symptoms, thinking there could be an infection. She has finished the antibiotic and currently has no issues. She is still pumping exclusively. The original products were not returned for evaluation/investigation. Therefore, no definitive conclusion regarding the root cause of the reported event can be made.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419937-2010-00037 |
| MDR Report Key | 1899177 |
| Report Source | 04 |
| Date Received | 2010-10-29 |
| Date of Report | 2010-09-30 |
| Date of Event | 2010-09-30 |
| Date Mfgr Received | 2010-09-30 |
| Date Added to Maude | 2011-02-22 |
| 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 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 |
| Generic Name | NURSING PAD, HYDROGEL |
| Product Code | NTC |
| Date Received | 2010-10-29 |
| Catalog Number | UNK |
| 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 | 2010-10-29 |