MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for ADAPT FLAT BARRIER RING 7805 manufactured by Hollister Incorporated.
[132503484]
No sample received. Dhr review conducted and no issues found. The root cause of the end user's reported yeast infection cannot be determined. This will continue to be monitored in hollister's post marketed complaint system and actions will be taken if/when indicated.
Patient Sequence No: 1, Text Type: N, H10
[132503485]
It was reported that the end user developed redness under his urostomy barrier ring which extending down toward his groin. This started about 2 weeks ago and there was no pain or itching. He went to the doctor who diagnosed it as a yeast infection and prescribed nystop. Hollister will be providing a different barrier ring formulation for end user to try.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2019-00001 |
| MDR Report Key | 8227514 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-12-20 |
| Date Mfgr Received | 2019-01-03 |
| Date Added to Maude | 2019-01-08 |
| 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 | 0 |
| Brand Name | ADAPT FLAT BARRIER RING |
| Generic Name | ADAPT FLAT BARRIER RINGS 2" |
| Product Code | EXB |
| Date Received | 2019-01-08 |
| Catalog Number | 7805 |
| Lot Number | 8K022 |
| 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 | 2019-01-08 |