MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-16 for TENDER CARE HYDROGEL PADS 87123NA manufactured by Medela Llc.
[92153631]
In follow up with the customer on (b)(6) 2017, the customer responded that she may have an allergy to one of the ingredients in the hydrogel pads that she didn't know about, and will have to avoid coming in contact with it in the future. She indicated that she was prescribed an antibiotic and stopped using the hydrogel pads immediately, though the product was very helpful in doing what it was designed to do, but just didn't work with her sensitive skin. She stated that she discarded the product. Reported issues of rash related to the hydrogel pads were investigated under (b)(4), which determined the probable root causes to be (1) customers with glycerin allergies experiencing aggressive immune reactions due to the fact that glycerin is an integral ingredient in the hydrogel pads and (2) pathogens or allergens that come in contact with exposed hydrogel pads which would subsequently be introduced to the user? S breast.
Patient Sequence No: 1, Text Type: N, H10
[92153632]
On (b)(6) 2017, the customer alleged via email to medela llc that she used the tender care hydrogel pads for the first time and experienced a severe allergic reaction. The product worked well at first until her entire breasts became covered in hives, swollen and red all over. To her knowledge, she didn't have allergies to the listed ingredients, but did indicate an allergy to latex. She wanted to know if there was any latex in the product; otherwise, she may have discovered another allergy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2017-00320 |
| MDR Report Key | 7036384 |
| Report Source | CONSUMER |
| Date Received | 2017-11-16 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-10-12 |
| Date Facility Aware | 2017-10-24 |
| Date Mfgr Received | 2017-10-24 |
| Date Added to Maude | 2017-11-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT SOKOLOWSKI |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer G1 | MEDELA LLC |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TENDER CARE HYDROGEL PADS |
| Generic Name | NURSING PAD, HYDROGEL |
| Product Code | NTC |
| Date Received | 2017-11-16 |
| Model Number | 87123NA |
| Catalog Number | 87123NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA LLC |
| Manufacturer Address | 1101 CORPORATE DRIVE MCHENRY 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-16 |