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

Catalog Number 18193

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

Patient Problem Skin Irritation (2076)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Dhr review not possible because lot number not known.Sample review not possible because no sample available.Trend data reviewed and no adverse trend observed.The root cause of the reported skin irritation under the pouch film cannot be determined.Patient's weight not known so estimation was used.

Event Description

It was reported that the end user wore his ostomy pouch such that it rested directly against his skin.This trapped moisture and caused skin irritation and redness.His doctor prescribed triamcinolone acetonide cream.The end user is using the cream and preventing his pouch from resting directly on his skin.The redness and irritation is clearing up.

• 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: 9481603
• MDR Text Key: 176762005
• Report Number: 1119193-2019-00044
• 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: 12/17/2019

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: 18193
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/17/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 84