MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for NEW IMAGE CONVEX SKIN BARRIER WITH TAPE BORDER 44MM, 1 3/4 INCH PRE SIZED OPENIN 14904 manufactured by Hollister Incorporated.
[130026020]
Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review was conducted and found to be complete and accurate. Sample review not possible because no sample available. Trend data reviewed and no adverse trend observed.
Patient Sequence No: 1, Text Type: N, H10
[130026021]
It was reported that an end user experienced blisters under the tape border of the barrier. He was prescribed a steroid with antifungal cream, nystatin ointment, and fluocinonide ointment. The skin is no longer blistered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2018-00047 |
| MDR Report Key | 8151001 |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-09-20 |
| Date Added to Maude | 2018-12-11 |
| 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. 600483781 |
| Manufacturer Country | US |
| Manufacturer Postal | 600483781 |
| Manufacturer Phone | 8476802170 |
| Manufacturer G1 | HOLLISTER INCORPORATED |
| Manufacturer Street | 366 DRAFT AVENUE |
| Manufacturer City | STUARTS DRAFT VA 244779998 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 244779998 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEW IMAGE CONVEX SKIN BARRIER WITH TAPE BORDER 44MM, 1 3/4 INCH PRE SIZED OPENIN |
| Generic Name | NEW IMAGE CONVEX SKIN BARRIER WITH TAPE BORDER |
| Product Code | EXB |
| Date Received | 2018-12-11 |
| Catalog Number | 14904 |
| Lot Number | 8I202 |
| 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 600483781 US 600483781 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-11 |