MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER

Catalog Number 14903

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Lot number not provided so dhr review is not possible.Sample not returned so a sample evaluation is not possible.Trend data reviewed and no adverse trend observed.Despite numerous attempts, no further event information could be obtained.End user's age and weight estimated because actual information is not known.

Event Description

An end user reported that the adhesive on the ostomy barrier products sometimes causes irritation.A doctor prescribed a powder and antibiotics.No further information is known.

• Brand Name: NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE CONVEX FLEXTEND 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: 8911548
• MDR Text Key: 155701833
• Report Number: 1119193-2019-00036
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Weight: 79