MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE CONVEX PRESIZED OSTOMY BARRIER

Catalog Number 14905

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

Patient Problem Itching Sensation (1943)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Since lot number not provided dhr review not possible.Sample not returned so sample evaluation not possible.Patient's weight and race not known.Root cause of reported itchy and bleeding skin under the barrier cannot be determined.

Event Description

It was reported that an end user was using the hollister new image ostomy barrier and her skin started itching under the barrier; she would scratch it and it would start bleeding.The doctor prescribed nystatin.That did not help.She will be trialing a different formulation of hollister's ostomy barriers to see if that makes a difference.

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Since lot number not provided dhr review not possible.Sample not returned so sample evaluation not possible.Patient's weight and race not known.Root cause of reported itchy and bleeding skin under the barrier cannot be determined.

Event Description

It was reported that an end user was using the hollister new image ostomy barrier and her skin started itching under the barrier; she would scratch it and it would start bleeding.The doctor prescribed nystatin.That did not help.She will be trialing a different formulation of hollister's ostomy barriers to see if that makes a difference.

• Brand Name: NEW IMAGE CONVEX PRESIZED OSTOMY BARRIER
• Type of Device: NEW IMAGE CONVEX PRESIZED OSTOMY BARRIER
• 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: 13002976
• MDR Text Key: 285327978
• Report Number: 1119193-2021-00038
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG