MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT MEDICAL ADHESIVE SPRAY

Catalog Number 7730

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

The end user's weight is not known so an estimate was used.A dhr review was performed on the provided lot number.The batch review results were acceptable and no evidence of any deviations or abnormalities were noted in production.Despite repeated attempts hollister has been unable to reach the end user for further information.It is not known what type of skin breakdown the end user experienced or how the adhesive spray caused or contributed to this reported injury.A trend analysis was conducted and no adverse trends were observed for this type of complaint.

Event Description

It was reported that an ostomate started to experience skin breakdown in (b)(6) 2020 while using hollister medical adhesive spray under her ostomy barrier.The end user stated that the skin breakdown was due to the medial adhesive spray.As a result of the breakdown, she reported that she needed to have surgery on the area.

• Brand Name: ADAPT MEDICAL ADHESIVE SPRAY
• Type of Device: ADAPT MEDICAL ADHESIVE SPRAY
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): AURENA LABORATORIES AB; fjarrviksvagen 22; karlstad 65350 ; SW 65350
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048-3781 ; 8476802170
• MDR Report Key: 11612874
• MDR Text Key: 259997270
• Report Number: 1480288-2021-00001
• Device Sequence Number: 1
• Product Code: KOX
• 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: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 7730
• Device Lot Number: 9C188
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 64