MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-15 for RESTORE manufactured by Hollister Incorporated.
[97308678]
Neither samples, skus, nor lot numbers were provided by the patient's mother, and the patient's mother is unwilling to provide further details. Hollister incorporated is unable to verify the reported information with any medical professional. Since the (b)(6) girl was reported to have had contact dermatitis on both legs prior to the use of the cleanser and since event details including medical professional assessments are not available, it cannot be determined if this reported reaction was due to a hollister restore cleanser or is associated with the pre-existing contact dermatitis.
Patient Sequence No: 1, Text Type: N, H10
[97308679]
It was reported that the patient has contact dermatitis on both legs and the doctor used a hollister restore cleanser on the legs before taking a swab and then the doctor changed it to a biopsy. The patient's mother stated that her child reacts to everything. The patient's mother stated that after using the restore cleanser on the patient's legs it ate through the layers of skin and she started shedding her skin. The patient's mother then stated that the patient was flown to a hospital and stayed there for two weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1480288-2018-00001 |
| MDR Report Key | 7192340 |
| Date Received | 2018-01-15 |
| Date of Report | 2018-01-15 |
| Date Mfgr Received | 2017-12-19 |
| Date Added to Maude | 2018-01-15 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR BENJAMIN LICHTENWALNER |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE IL 600483781 |
| Manufacturer Country | US |
| Manufacturer Postal | 600483781 |
| Manufacturer Phone | 8479183497 |
| Manufacturer G1 | HOLLISTER INCORPORATED |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE IL 600483781 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600483781 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESTORE |
| Generic Name | WOUND OR SKIN CLEANSER |
| Product Code | KMF |
| Date Received | 2018-01-15 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US 600483781 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-01-15 |