MAUDE Adverse Event Report: CARDINAL HEALTH FORT MILL SHOULDER ARTHROSCOPY (SASBB)575; GENERAL SURGERY TRAY (KIT)

Model Number SOP40SASBC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

During a shoulder arthroscopy the patient developed a rash from the drape, u, 60 x 72 in, fan folded, w/adhesive, ns requiring cleansing of affected skin and application of bacitracin.We were unable to conduct a device history record review for the given product quality report, as the lot provided is invalid.However, a verification of the final inspection records for the given product catalog number over the last 6 months, does not show an incidence or trend related to the issue reported.All devices are made with qualified, tested and approved materials.We also verified that the operators are certified in their operations and in compliance with applicable standard production method (spm).The product is randomly inspected according to the approved sampling plan where this condition is verified by the qa inspectors.Since a sample is not available, a root cause for this issue could not be determined.Based on the process evaluation and the investigation conducted, we are unable to determine the root cause for this issue.If a sample is returned at a later date, an addendum to this investigation will be performed.

Event Description

This account is having issues with pack sop40sasbc lot #449418 and the u-drape 8476.The patients are getting a rash on shoulders.Date of event: (b)(6) 2021.

Manufacturer Narrative

Mdr supplemental report being filed due to the event date on the initial report was entered incorrectly.The correct date is now being submitted.No other changes to the report are required.

Event Description

This account is having issues with pack sop40sasbc lot #449418 and the u-drape 8476.The patient developed a rash on shoulders.

• Brand Name: SHOULDER ARTHROSCOPY (SASBB)575
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CARDINAL HEALTH FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• Manufacturer (Section G): CARDINAL HEALTH FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6965984
• MDR Text Key: 89919012
• Report Number: 1423537-2017-00132
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10887488532561
• UDI-Public: 10887488532561
• 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,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SOP40SASBC
• Device Catalogue Number: SOP40SASBC
• Device Lot Number: 449418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/03/2017
• Date Manufacturer Received: 10/03/2017
• Date Device Manufactured: 07/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other