MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-23 for NEW IMAGE TWO-PIECE POUCHING SYSTEM 14203 manufactured by Hollister Incorporated.
[142780379]
No sample received so a device examination not possible. Lot number provided. Device history record review conducted and no issues identified. The root cause of the reported skin issue cannot be identified. 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
[142780380]
It was reported that the end user experienced blisters, weeping skin and sores around the stoma after using the 14203 skin barrier. Stool then started undermining his barrier causing skin irritation. He was seen in the er and antibiotics given. The skin has improved but sores are starting again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2019-00013 |
| MDR Report Key | 8540445 |
| Report Source | CONSUMER |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-04-23 |
| 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 TWO-PIECE POUCHING SYSTEM |
| Generic Name | NEW IMAGE FLEXWEAR SKIN BARRIER WITH TAPE BORDER |
| Product Code | EXB |
| Date Received | 2019-04-23 |
| Catalog Number | 14203 |
| Lot Number | 8K082 |
| 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 | 2019-04-23 |