MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-19 for NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1-1/4" CTF 14602 manufactured by Hollister Incorporated.
[139244682]
Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review not possible because lot number not known. Sample review not possible because no sample available. Trend data reviewed and no adverse trend observed. Weight of end user not known so estimation was used.
Patient Sequence No: 1, Text Type: N, H10
[139244683]
It was reported that an end user received his stoma in 2016 and almost immediately, noticed red irritation under the tape portion of his barrier. His doctor prescribed nystatin powder, had him use a spray, and then apply his appliance. The red irritation never went away despite using the powder and spray. He saw a nurse yesterday who said to stop using the powder and spray, cut off the tape border and use a different tape. He did this and things are now improving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2019-00008 |
| MDR Report Key | 8433935 |
| Report Source | CONSUMER |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-19 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2019-03-18 |
| Date Added to Maude | 2019-03-19 |
| 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 FLEXTEND SKIN BARRIER WITH TAPE BORDER 1-1/4" CTF |
| Generic Name | NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER |
| Product Code | EXB |
| Date Received | 2019-03-19 |
| Catalog Number | 14602 |
| 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 | 2019-03-19 |