MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER CONVEX LNR CERAPLUS POUCH WITH CTF BARRIER

Catalog Number 89811

Device Problem Material Separation (1562)

Patient Problem Concussion (2192)

Event Date 08/28/2022

Event Type  Injury  

Event Description

It was reported that an ostomate using hollister premier pouching system slipped and fell when the edge seal of the pouch opened, and effluent leaked out.The end user reported that she hit her head when she fell and went to the ed to have it evaluated.The end user reported that in the ed she had a ct scan of her head which did not show any problems and was discharged home on pain pills and a muscle relaxer.

Manufacturer Narrative

Trend analysis conducted and no other complaints of slips and falls on effluent leakage identified.Device history record (dhr) review conducted and the records were found to be complete and accurate.Sample not yet returned so sample evaluation not possible.Root cause of edge seal failure cannot be determined.

• Brand Name: PREMIER CONVEX LNR CERAPLUS POUCH WITH CTF BARRIER
• Type of Device: PREMIER CONVEX LNR CERAPLUS POUCH WITH CTF BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 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 60048-3781 ; 8476802170
• MDR Report Key: 15495577
• MDR Text Key: 300700878
• Report Number: 1119193-2022-00034
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 89811
• Device Lot Number: 1K042, 2E262 & 2H102
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 86 KG