MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-07-25 for TENDER CARE HYDROGEL PADS 87123NA manufactured by Medela Llc.
[80987313]
A replacement box of hydrogel pads were sent to the customer so she could return them to a store for a refund. On (b)(6) 2017, a medela clinician followed up with the customer and she reported that she went to urgent care and received a steroid shot and also went to her doctor and was prescribed diprolene cream. She has not used the pads since the one time on (b)(6) 2017. She indicated that the rash was clearing up, but as of (b)(6) 2017, there was still redness outlining the pads. The product involved in the complaint has not been returned for evaluation/investigation at this time. Reported issues of rash were investigated under in (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 or (2) pathogens or allergens that come in contact with exposed hydrogel pads which would subsequently be introduced to the user? S breast. The customer filed a voluntary medwatch report under mw5070852.
Patient Sequence No: 1, Text Type: N, H10
[80987314]
On (b)(6) 2017, the customer alleged that she used the tender care hydrogel pads on (b)(6) 2017 and was apparently allergic to them, as they caused her skin to become red and she developed a rash covering the area where the pad was.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2017-00206 |
| MDR Report Key | 6742009 |
| Report Source | CONSUMER |
| Date Received | 2017-07-25 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-07-03 |
| Date Facility Aware | 2017-07-11 |
| Date Mfgr Received | 2017-07-11 |
| Date Added to Maude | 2017-07-25 |
| 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 | 2017-07-25 |
| 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 IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-25 |