MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-02 for ADAPT CERARING FLAT BARRIER RING 8805 manufactured by Hollister Incorporated.
[122349555]
No sample received and no lot number provided. Without the sample or lot number hollister is unable to perform a full investigation regarding the skin issue. 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
[122349556]
It was reported that an end user developed red, blistering and bleeding peristomal skin 1 1/2 hours after using the adapt ceraring for the first time. The end user applied hot compresses and the bleeding stopped. The area improved but she went to the er that evening. They applied and then prescribed lidocaine topical ointment for her to apply at home. She stopped using the adapt ceraring and the peristomal skin is fine now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2018-00037 |
| MDR Report Key | 7926595 |
| Report Source | CONSUMER |
| Date Received | 2018-10-02 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-09-27 |
| Date Mfgr Received | 2018-09-28 |
| Date Added to Maude | 2018-10-02 |
| 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 | ADAPT CERARING FLAT BARRIER RING |
| Generic Name | ADAPT CERARING FLAT BARRIER RING |
| Product Code | EXB |
| Date Received | 2018-10-02 |
| Catalog Number | 8805 |
| 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 INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US 600483781 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-02 |