MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE DRAINABLE POUCH WITH FILTER AND LOCK 'N ROLL CLOSURE

Catalog Number 18184

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

Patient Problem Rash (2033)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

End user's weight not known so estimate used.Lot number and sample not provided so sample and dhr investigation not possible.Trend review conducted and no adverse trends were observed for this reported issue.Biocompatibility testing has been performed in accordance with iso (b)(4) and materials were found to be non-sensitizers.

Event Description

It was reported that an end user has been experiencing a skin rash under the non-woven comfort panel portion of her hollister ostomy pouch.Her doctor stated it was allergic contact dermatitis.She has been prescribed steroid cream and antibiotics from which she is seeing some improvement.

• Brand Name: NEW IMAGE DRAINABLE POUCH WITH FILTER AND LOCK 'N ROLL CLOSURE
• Type of Device: NEW IMAGE DRAINABLE POUCH WITH FILTER AND LOCK 'N ROLL CLOSURE
• Manufacturer (Section D): HOLLISTER INCORPORATED; 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. 60048-3781 ; 8476802170
• MDR Report Key: 11231498
• MDR Text Key: 228854977
• Report Number: 1119193-2021-00001
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18184
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• 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: 64 YR
• Patient Weight: 84