MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-04 for NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER 11204 manufactured by Hollister Incorporated.
[129299509]
Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review not possible because not number not known. Sample review not possible because no sample available. Trend data reviewed and no adverse trend observed.
Patient Sequence No: 1, Text Type: N, H10
[129299510]
It was reported that an end user experienced raw skin under the tape portion of the barrier. End user needed to be hospitalized for 2 days to receive pain shots during routine stoma care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2018-00041 |
| MDR Report Key | 8130908 |
| Report Source | CONSUMER |
| Date Received | 2018-12-04 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-11-19 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-04 |
| 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 | 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 | 2018-12-04 |
| Catalog Number | 11204 |
| Lot Number | UNKNOWN |
| 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 | 2018-12-04 |