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 Pain (1994); Rash (2033); Increased Sensitivity (2065); Skin Inflammation (2443); Blood Loss (2597)

Event Date 01/20/2020

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

Homebound end user reports "she first tried sensicare (ssc) barrier wipe and adhesive remover wipes, and had some skin irritation, but then ordered the ssc adhesive releaser spray and ssc barrier spray because, she thought they would have different ingredients.She used both sprays on (b)(6) 2020 and had a severe reaction that included elevated bumps, widespread rash, bleeding and pain.As she is homebound, her physician came to see her and diagnosed her with an allergic reaction.Her home nurse conducted a patch test on her forearm, and she reports she had the same reaction.She was prescribed oral prednisone in a tapering dose, and topical steroid.Her home health nurse applied a coloplast 4x4 barrier to her skin and attached her ostomy pouches to that.She reports she has had similar reaction to hollister adhesive remover and hollister wafers in the past.She states she has completed the course of prednisone, and her skin is now resolved.".

• 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: 9729580
• MDR Text Key: 192477492
• Report Number: 1049092-2020-00097
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• 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: 02/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36