MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BANDAGE,FABRIC,TOUCHFREE,30CT,3/4X3"

Catalog Number CUR1930F

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Itching Sensation (1943); Tachycardia (2095)

Event Date 09/27/2022

Event Type  Injury  

Event Description

According to the customer after a procedure on (b)(6) 2022 an adhesive bandage was placed on her back to cover her surgical site and left on for 48 hours per hospital instruction.When removing the bandage on (b)(6) 2022 the customer stated she was experiencing 'severe itching, shortness of breath, and elevated heart rate'.

Manufacturer Narrative

According to the customer after a procedure on (b)(6) 2022 an adhesive bandage was placed on her back to cover her surgical site and left on for 48 hours per hospital instruction.When removing the bandage on (b)(6) 2022 the customer stated she was experiencing 'severe itching, shortness of breath, and elevated heart rate'.The customer stated she went to the emergency room and was prescribed hydroxyzine hcl and received hydrocortisone cream 1% to treat the skin irritation and itching.Per the customer she has existing health issues with chronic itching and allergies to latex and adhesive.The sample was returned but a definitive root cause could not be determined at this time.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: BANDAGE,FABRIC,TOUCHFREE,30CT,3/4X3"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15960598
• MDR Text Key: 305277964
• Report Number: 1417592-2022-00236
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2022

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: CUR1930F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female