MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER SOFT CONVEX DRAINABLE LOCK N ROLL POUCHING SYSTEM

Catalog Number 85711

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

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

Event Date 12/31/2021

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed for tape causing skin irritation.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 skin irritation under the tape border cannot be determined.

Event Description

It was reported that about 3 weeks ago an end user started noticing skin irritation, itchy and painful skin under the tape border of the hollister ostomy appliance.She attempted to treat it at home with bacitracin ointment but it did not help.She called her doctor who prescribed cefoxitin oral antibiotics as a preventive against a bacterial skin infection.The doctor did not see her or the irritated area on her skin before prescribing.End user called hollister at which time the crusting technique was explained to her.She is now using the stoma powder under the tape border for the irritated area and the area is clearing up.

• Brand Name: PREMIER SOFT CONVEX DRAINABLE LOCK N ROLL POUCHING SYSTEM
• Type of Device: PREMIER SOFT CONVEX DRAINABLE LOCK N ROLL POUCHING SYSTEM
• 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: 13284988
• MDR Text Key: 289066469
• Report Number: 1119193-2022-00001
• 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: 01/18/2022

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: 85711
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/18/2022
• 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
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 68 KG