MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-28 for NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER 14910 manufactured by Hollister Incroporated.
[176647906]
Lot number not provided so dhr review is not possible. Sample not returned so a sample evaluation is not possible. Trend data reviewed and no adverse trend observed. End user states that the device did not malfunction. The product did not fit well with his particular stoma shape and when he switched to a product that better fit him, the reported issue went away. End user's weight estimated because actual information is not known.
Patient Sequence No: 1, Text Type: N, H10
[176647907]
It was reported that an end user experienced urine leakage under the hollister ostomy appliance due a hernia causing his stoma to take on an odd shape. The leakage led to skin irritation and skin infection. The end user was prescribed oral antibiotics for 1 week and the skin infection cleared up. He has since changed to a different hollister appliance and is no longer experiencing the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2020-00003 |
| MDR Report Key | 9637935 |
| Report Source | CONSUMER |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-01-28 |
| 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 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 CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER |
| Generic Name | NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER |
| Product Code | EXB |
| Date Received | 2020-01-28 |
| Catalog Number | 14910 |
| 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 INCROPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US 600483781 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-28 |