MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; DR GILL'S CDS

Model Number CDS983189G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Rash (2033)

Event Date 09/18/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, on (b)(6) 2022 a patient developed a 'strange rash' relating to the use of a drape after a laminectomy procedure that was noticed by the physicians assistant and surgeon.Per the customer, it started on the abdomen and progressed.The patient denies use of new medications or foods according to the customer contact.A dermatology consult did not find a known cause of the 'rash'.He has no known drug allergies.According to the customer the patient's rash required steroids and took 'a while' to clear but it has cleared after 'several interventions'.The sample is not available to be returned for evaluation.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.

Event Description

According to the customer contact, on (b)(6) 2022 a patient developed a 'strange rash' relating to the use of a drape after a laminectomy procedure that was noticed by the physicians assistant and surgeon.

• Brand Name: Medline Industries, Inc.
• Type of Device: DR GILL'S CDS
• 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: 15893938
• MDR Text Key: 304603566
• Report Number: 1423395-2022-00040
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10195327164485
• UDI-Public: 10195327164485
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDS983189G
• Device Catalogue Number: CDS983189G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2022
• 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): Other