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

Catalog Number 15A00

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

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

Although hollister does not sell (b)(4) in the us, a similar ostomy barrier product, (b)(4), is sold in the us.Trend analysis conducted and no adverse trends observed over the last 3 years.Device history records (dhr) could not be reviewed because lot number was not provided.Sample not returned so sample evaluation not possible.Root cause of the skin reaction to the hollister ostomy product cannot be determined.

Event Description

It was reported that about one week after radiation therapy, an end user started to experience itching at the stoma under the hollister conform 2 ostomy barrier.It was reported that the itching lead to skin redness and oozing which spread to other areas of his body including skin ridges & folds and the eyes.It was reported that the end user went to a dermatologist who conducted allergy testing which showed he reacted to hollister products.It was further reported that he was prescribed a milky tincture to treat the areas.It was reported that the affected areas have now scabbed over.It was reported that according to the doctors at the dermatology clinic, it's due to an allergic reaction that blossomed after his immune system rebooted after radiation therapy.

• Brand Name: CONFORM 2 FLEXTEND SOFT CONVEX CUT TO FIT OSTOMY BARRIER
• Type of Device: CONFORM 2 FLEXTEND SOFT CONVEX 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: 14547229
• MDR Text Key: 292968019
• Report Number: 3016675012-2022-00003
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 15A00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• 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