MAUDE Adverse Event Report: CONVATEC INC RELEASE AGENT; SOLVENT, ADHESIVE TAPE

Model Number 413499

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported by the mother of a (b)(6)-year-old end user that "back in june end user had back surgery.Mother was given sensi-care adhesive releaser spray as accessory for removing a non-convatec wound dressing.After one application she noted a red itchy rash with big and small bumps, on back, the exact image of the border of the dressing which spread up and down her back and around to the front of her abdomen.This took a week or two to resolve after never using the adhesive releaser.Mother took end user to a dermatologist and it has been determined she is allergic to one thing acrylate.Mother requesting to know if adhesive releaser contains acrylates of any kind." the product was discarded.It was noted that the end user also had skin reactions with two other products, an unknown tape and the ekg (electrocardiogram)paste.No additional event information or photograph was provided.

• Brand Name: RELEASE AGENT
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 10443145
• MDR Text Key: 204040962
• Report Number: 1049092-2020-00163
• Device Sequence Number: 1
• Product Code: KOX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413499
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5