MAUDE Adverse Event Report: HOLLISTER INCROPORATED CERAPLUS ONE-PIECE FLAT DRAINABLE POUCH; CERAPLUS ONE-PIECE FLAT DRAINABLE POUCH - FLAT BARRIER, LOCK 'N ROLL CLOSURE

Model Number 89301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Lot number not provided so device history records could not be reviewed.Sample not returned so sample evaluation not possible.Root cause of reported irritation under the ostomy barrier cannot be determined.

Event Description

It was reported that a new ostomate experienced blisters under the hollister ostomy flange 3 days after it was applied.It was reported that her skin has since improved since using steroid cream.She reports using a different hollister barrier now with good results.

• Brand Name: CERAPLUS ONE-PIECE FLAT DRAINABLE POUCH
• Type of Device: CERAPLUS ONE-PIECE FLAT DRAINABLE POUCH - FLAT BARRIER, LOCK 'N ROLL CLOSURE
• 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: 16035823
• MDR Text Key: 306014606
• Report Number: 1119193-2022-00041
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/22/2022

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 Model Number: 89301
• Device Catalogue Number: 89301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 12/22/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female