MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER

Catalog Number 14104

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation (2443)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

Sample not returned so a sample evaluation is not possible.Lot number not known so dhr review is not possible.Trend data reviewed and no adverse trend observed.The root cause of the reported round, raised bumps on the end user's peristomal skin cannot be determined.

Event Description

It was reported that the end user experienced red, raised, painful bumps on her peristomal skin under the new image barrier.She denies any effluent leakage onto her skin.The doctor thought it might be a yeast infection and prescribed diflucan oral medication.The bumps remain so she will try a different barrier formulation.

• Brand Name: NEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER
• 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: 8305820
• MDR Text Key: 135032693
• Report Number: 1119193-2019-00005
• 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: 02/04/2019

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: 14104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/05/2019
• 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: 45 YR
• Patient Weight: 73