MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER 11203 manufactured by Hollister Incorporated.
[187618925]
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
[187618926]
It was reported that the end user had colostomy surgery in (b)(6) 2017. In (b)(6) 2019 he started having red, itchy rash wherever the barrier touched his skin under the new image ostomy barrier. He tried managing the irritation on his own but the area did not improve. He went to his doctor in (b)(6) 2019 and was provide triamcinolone acetonide ointment 0. 1%. The area cleared up with the use of the ointment but then recurred. Hollister customer service is sending out different samples for him to try.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2020-00006 |
| MDR Report Key | 9872369 |
| Report Source | CONSUMER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Catalog Number | 11203 |
| Lot Number | 9D072 |
| 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 | 2020-03-24 |