MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-07 for TENDER CARE HYDROGEL PADS 87123 manufactured by Medela Llc.
[110362607]
Customer service replied with an response, encouraging the customer to make contact via phone so that her issue could appropriately be addressed. In follow up by a complaint handler with the customer on (b)(6) 2018, the customer responded that she started using the gel pads 3 days after delivery for irritated nipples from breastfeeding. She stated that she only wore the gel pads for about 2 hours when she noticed a burning sensation and then saw marks on her breast. She indicated that she stopped using the gel pads, visited her lactation consultant (who consulted her obgyn), and was prescribed a compound steroid cream. The customer indicated that the burns are still noticeable, but are healing. She stated that she has discarded the unused 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
[110362608]
On (b)(6) 2018, the customer alleged to medela llc via email that the tender care hydrogel pads burned her skin terribly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2018-00141 |
| MDR Report Key | 7577801 |
| Report Source | CONSUMER |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-05-30 |
| Date Added to Maude | 2018-06-07 |
| 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 | JAN KLOIBER |
| 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 | 2018-06-07 |
| Model Number | 87123 |
| Catalog Number | 87123 |
| Lot Number | 051016 |
| 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 IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-07 |