MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-11-17 for MODERMA FLEX UROSTOMY POUCH WITH CONVEX SKIN BARRIER 2969139 manufactured by Hollister Incorporated.
[92360145]
A device malfunction has not been alleged or determined. Additional information was received on november 16th from the clinical nurse who cared for the patient. The opinion of the treating nurse is that the presence of convexity against the patient's peristomal skin caused the pressure area. The use of convexity for patients with flush or receding stomas is the standard practice; however, the potential exists for pressure-related issues that should be monitored during its use to determine if the benefits of using the product outweigh the risk of effluent leakage.
Patient Sequence No: 1, Text Type: N, H10
[92360146]
It was reported that the patient presented to the hospital on (b)(6) 2017 with a stage 2 pressure injury near his urinary stoma which was attributed to the hollister convex urostomy pouch. The patient was treated through (b)(6) 2017 with over 42 visits to the clinic. The pressure ulcer has healed. It was noted by the clinic that the patient did have a weight gain which is believed to have contributed to the pressure ulcer occurring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2017-00036 |
| MDR Report Key | 7042267 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-05-08 |
| Report Date | 2017-09-06 |
| Date Reported to Mfgr | 2017-09-06 |
| Date Mfgr Received | 2017-09-20 |
| Date Added to Maude | 2017-11-17 |
| 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 | MR BENJAMIN LICHTENWALNER |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE IL 600483781 |
| Manufacturer Country | US |
| Manufacturer Postal | 600483781 |
| Manufacturer Phone | 8479183497 |
| 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 | MODERMA FLEX UROSTOMY POUCH WITH CONVEX SKIN BARRIER |
| Generic Name | UROSTOMY POUCH |
| Product Code | EXG |
| Date Received | 2017-11-17 |
| Model Number | 2969139 |
| Catalog Number | 2969139 |
| 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 | 366 DRAFT AVENUE STUARTS DRAFT VA 244779998 US 244779998 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-17 |