MAUDE Adverse Event Report: HOLLISTER INCROPORATED HOLLISTER PREMIER FLEXTEND CUT TO FIT UROSTOMY APPLIANCE; HOLLISTER PREMIER FLEXTEND CUT TO FIT UROSTOMY APPLIANCEAPPLIANCE

Catalog Number 84590

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Dhr review completed and no issues identified.Sample not returned so sample evaluation not possible.Root cause of reported blisters under the tape border cannot be determined.

Event Description

It was reported that an end user developed blisters under the tape border of the hollister premier ostomy appliance in the beginning of october.He has been prescribed nystop antifungal powder.Hollister will send out a different barrier product that does not have a tape border.

• Brand Name: HOLLISTER PREMIER FLEXTEND CUT TO FIT UROSTOMY APPLIANCE
• Type of Device: HOLLISTER PREMIER FLEXTEND CUT TO FIT UROSTOMY APPLIANCEAPPLIANCE
• 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: 13053193
• MDR Text Key: 282567175
• Report Number: 1119193-2021-00036
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 84590
• Device Lot Number: 1H042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 102 KG