MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-03 for NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER 11203 manufactured by Hollister Incorporated.
[187619318]
Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review conducted and no issues identified. Sample review not possible because no sample available. Trend data reviewed and no adverse trend observed. Root cause of this reported issue cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[187619319]
It was reported that the end user had colostomy surgery on (b)(6) 2018 and started having skin irritation under the new image ostomy barrier in (b)(6) 2019. She saw her dermatologist numerous times and was prescribed nystatin fungal powder on (b)(6) 2019 and clobetasol steroid cream on (b)(6) 2019 to address the irritation. Neither completely worked. She is now experiencing weepy skin below the stoma. She is using a liquid skin barrier with some relief. The doctor said that her skin issues may be related to her ulcerative colitis. She will continue to work with her visiting nurse to see if other barrier samples help her skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2020-00004 |
| MDR Report Key | 9780830 |
| Report Source | CONSUMER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-03 |
| 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 | MS. LINDA WISOWATY |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE., |
| Manufacturer Country | US |
| Manufacturer Phone | 6802170 |
| Manufacturer G1 | HOLLISTER INCORPORATED |
| Manufacturer Street | 366 DRAFT AVENUE |
| Manufacturer City | STUARTS DRAFT, VA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER |
| Generic Name | NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER |
| Product Code | EXB |
| Date Received | 2020-03-03 |
| Catalog Number | 11203 |
| Lot Number | 0A132 |
| Operator | LAY USER/PATIENT |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |