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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER

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HOLLISTER INCORPORATED PREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER Back to Search Results
Catalog Number 8371
Device Problem Insufficient Information (3190)
Patient Problems Laceration(s) (1946); Blood Loss (2597)
Event Date 11/01/2018
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
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Brand NamePREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER
Type of DevicePREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister drive
libertyville IL 60048 3781
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft VA 24477 9998
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville, IL 60046-3781
8476802170
MDR Report Key8518470
MDR Text Key142079173
Report Number1119193-2019-00010
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8371
Device Lot Number7I062
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/16/2019 Patient Sequence Number: 1
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