MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER ONE-PIECE DRAINABLE OSTOMY POUCH; PREMIER ONE-PIECE DRAINABLE OSTOMY POUCH - SOFT CONVEX CERAPLUS BARRIER

Model Number 8958

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

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 12/17/2022

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 tape border cannot be determined.

Event Description

It was reported that an end user experienced skin burning and itching sensation on her skin under the 8958 hollister premier ostomy appliance.She stated she nonetheless left the appliance in place until the return of her home health care nurse 3 days later.When the barrier was removed, she reported there were blisters and irritation under some areas of the tape border.She stated the home health care nurse cleansed the area and applied a transparent film dressing.Then she said the nurse applied an ostomy appliance.Two days later, the end user reported that she removed the appliance and the film dressing because her appliance was leaking.She reported that the area looked just as irritated and was instructed by her home health care nurse to go to the er.The end user reported that she went to the er and was told she had a fever, which indicated an infection and was placed on iv antibiotics.End user reports that the area is now clearing up and would like hollister to supplier with a different barrier.

• Brand Name: PREMIER ONE-PIECE DRAINABLE OSTOMY POUCH
• Type of Device: PREMIER ONE-PIECE DRAINABLE OSTOMY POUCH - SOFT CONVEX CERAPLUS 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: 16035396
• MDR Text Key: 306009827
• Report Number: 1119193-2022-00040
• 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: Other
• 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: 8958
• Device Catalogue Number: 8958
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 57 YR
• Patient Sex: Female