MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-20 for NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER 14804 manufactured by Hollister Incorporated.
[127930774]
Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review conducted based upon the lot number provided and found to be accurate and complete. Trend data reviewed and no adverse trend observed.
Patient Sequence No: 1, Text Type: N, H10
[127930775]
It was reported that an end user developed a red rash under the tape border of the barrier about 2 months ago. A doctor prescribed nystatin powder in case it was a yeast infection and cephalexin in case it was a bacterial infection. It cleared up a little but is coming back. Since it is under the tape portion of the appliance, hollister customer service will send him tapeless samples to try. This rash has not expanded beyond the original area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2018-00042 |
| MDR Report Key | 8090343 |
| Report Source | CONSUMER |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-09-15 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2015-03-21 |
| Date Added to Maude | 2018-11-20 |
| 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 CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER |
| Generic Name | NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER |
| Product Code | EXB |
| Date Received | 2018-11-20 |
| Catalog Number | 14804 |
| Lot Number | 5C212 |
| 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 | 2018-11-20 |