MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT PASTE; ADAPT PASTE 0.5 OZ TUBE

Catalog Number 79301

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/23/2019

Event Type  Injury  

Manufacturer Narrative

No sample received and no lot number provided.Without the sample or lot number hollister is unable to perform a full investigation regarding the skin issue.This will continue to be monitored in hollister's post marketed complaint system and actions will be taken if/when indicated.

Event Description

It was reported that the end user experienced an allergic reaction around the stoma in november after using the adapt stoma paste.She was prescribed a steroid ointment.She is now in a good state of health.

• Brand Name: ADAPT PASTE
• Type of Device: ADAPT PASTE 0.5 OZ TUBE
• 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: 8267858
• MDR Text Key: 133759532
• Report Number: 1119193-2019-00004
• 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: consumer,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2019

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: 79301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 01/22/2019
• 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: 72 YR
• Patient Weight: 60