MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-16 for PREMIER FLEXWEAR DRAINABLE POUCH WITH FILTER AND TAPE BORDER 8081 manufactured by Hollister Incorporated.
[142075645]
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 no issues identified. Trend data reviewed and no trend observed. The root cause of the end users generalized rash cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[142075646]
It was reported that an end user experienced a rash over his whole body and itching associated with the use of the ostomy appliance. End user was prescribed hydroxyzine pills and instructed to use hydrocortisone cream. He states it helps a little.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2019-00011 |
| MDR Report Key | 8518471 |
| Report Source | CONSUMER |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-03-22 |
| Date Added to Maude | 2019-04-16 |
| 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 600463781 |
| Manufacturer Country | US |
| Manufacturer Postal | 600463781 |
| 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 | PREMIER FLEXWEAR DRAINABLE POUCH WITH FILTER AND TAPE BORDER |
| Generic Name | PREMIER FLEXWARE DRAINABLE POUCH WITH FILTER AND TAPE BORDER |
| Product Code | EXB |
| Date Received | 2019-04-16 |
| Catalog Number | 8081 |
| Lot Number | 9A132 |
| 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 | 2019-04-16 |