MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-16 for PREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER 8371 manufactured by Hollister Incorporated.
[142079173]
Although requested, the end user never returned the ostomy appliance sample for evaluation. Without the benefit of the sample, a device evaluation is not possible. The dhr was reviewed and no problems identified. A trend analysis was conducted and no adverse trends for this failure observed. The root cause of the reported stoma laceration cannot be determined. It has not been concluded that the ostomy pouch caused or contributed to this reported event.
Patient Sequence No: 1, Text Type: N, H10
[142079174]
It was reported that an end user's stoma started bleeding from a cut in his stoma. He saw that the ostomy pouch filter had fallen into the pouch. He feels the filter cut his stoma. He went to the emergency room after applying pressure did not stop the bleeding. The emergency room used silver nitrate to stop the bleeding. They determined that he needed 1 unit of blood and was hospitalized for 24 hours. The stoma has now healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2019-00010 |
| MDR Report Key | 8518470 |
| Report Source | CONSUMER |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-03-25 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2019-04-16 |
| 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 600463781 |
| Manufacturer Country | US |
| Manufacturer Postal | 600463781 |
| 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 | PREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER |
| Generic Name | PREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER |
| Product Code | EXB |
| Date Received | 2019-04-16 |
| Catalog Number | 8371 |
| Lot Number | 7I062 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-04-16 |