MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DRESSING,COMPRESSION SYS,COFLEX,2 LAYER

Catalog Number AND7800

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

Patient Problem Local Reaction (2035)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported the end user experienced a rash/blisters described as a red papular rash affecting their right lower extremity, calf and ankle after medline coflex compression dressing was applied on (b)(6) 2020.It was reported the end user contacted the physician's office that afternoon complaining of itching and "wounds moving up the leg." it was reported, an incident report was completed and the end user was seen in clinic for treatment (date unknown) to include topical steroid and oral prednisone taper.Reportedly, end user is doing "much better as noted at last office visit." it has been reported; end user has allergies to the following medications; bacitracin, clobetasol, silver sulfadiazine, sulfa antibiotics.The sample is not available for return and evaluation.Therefore, a root cause cannot be established.No further information is available at this time.Due to the nature of the incident, and the need for medical intervention, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported, the end user developed a red papular rash to the right lower extremity affecting the calf and ankle.The end user was treated with topical steroids and a prednisone taper.

• Type of Device: DRESSING,COMPRESSION SYS,COFLEX,2 LAYER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10339864
• MDR Text Key: 209390646
• Report Number: 1423395-2020-00083
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AND7800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 105