MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-18 for NEW IMAGE TWO-PIECE POUCHING SYSTEM 14603 manufactured by Hollister Incorporated.
[124201687]
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. End user refused to provide age and weight so estimations were used in this report.
Patient Sequence No: 1, Text Type: N, H10
[124201688]
It was reported that an end user developed a round tiny spot (smaller than a pencil eraser) that was not bleeding but was red and tender with a shallow ulcer under the new image barrier on her peristomal skin. During a routine, follow up surgical appointment, her doctor opted to use silver nitrate on this area. The end user has since had two more of these areas under her barrier which she treated successfully on her own with stoma powder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2018-00038 |
| MDR Report Key | 7980555 |
| Report Source | CONSUMER |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-10-09 |
| Date Mfgr Received | 2018-10-09 |
| Date Added to Maude | 2018-10-18 |
| 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 FLEXTEND SKIN BARRIER WITH TAPE BORDER |
| Product Code | EXB |
| Date Received | 2018-10-18 |
| Catalog Number | 14603 |
| 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 | 2018-10-18 |