MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-05 for NEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER 14104 manufactured by Hollister Incroporated.
[135032693]
Sample not returned so a sample evaluation is not possible. Lot number not known so dhr review is not possible. Trend data reviewed and no adverse trend observed. The root cause of the reported round, raised bumps on the end user's peristomal skin cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[135032694]
It was reported that the end user experienced red, raised, painful bumps on her peristomal skin under the new image barrier. She denies any effluent leakage onto her skin. The doctor thought it might be a yeast infection and prescribed diflucan oral medication. The bumps remain so she will try a different barrier formulation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2019-00005 |
| MDR Report Key | 8305820 |
| Report Source | CONSUMER |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-04 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-01-29 |
| Date Added to Maude | 2019-02-05 |
| 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 | LINDA WISOWATY |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE IL 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 FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER |
| Generic Name | NEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER |
| Product Code | EXB |
| Date Received | 2019-02-05 |
| Catalog Number | 14104 |
| 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 INCROPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US 600483781 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-05 |