MAUDE Adverse Event Report: HOLLISTER INCROPORATED CONFORM 2 FLEXTEND CUT TO FIT OSTOMY BARRIER

Catalog Number 35500

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

Although hollister does not sell sku 35500 in the us, a similar ostomy barrier product, sku 14203, is sold in the us.Trend analysis conducted and no adverse trends observed over the last 3 years.Device history records (dhr) review conducted and was found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of the skin reaction to the adhesive cannot be determined.

Event Description

It was reported that an ostomate was experiencing a skin reaction to the hollister conform 2 ostomy barrier 10 days after surgery.It was reported that they changed the appliance to a convex barrier to see if it improved things, but it did not.It was further reported that the person saw a dermatologist for the skin reaction to the adhesive on the barrier and was prescribed a corticoïde medication.It is reported that the skin reaction has not resolved yet.

• Brand Name: CONFORM 2 FLEXTEND CUT TO FIT OSTOMY BARRIER
• Type of Device: CONFORM 2 FLEXTEND CUT TO FIT OSTOMY BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER LIETUVA UAB; oro parko str. 2, sergeicikai; karmelavos; kauno raj., LT-54 462; LH LT-54462
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 14135100
• MDR Text Key: 289433070
• Report Number: 3016675012-2022-00001
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 35500
• Device Lot Number: 1H169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• 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