MAUDE Adverse Event Report: CARDINAL HEALTH FORT MILL C SECTION PACK (CSGRJ)602; GENERAL SURGERY TRAY (KIT)

Model Number	SMA7CCSGRK
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) was reviewed for the reported lot number.  no quality issues were reported.The sample for this report was not returned for evaluation, therefore the root cause could not be determined for this event.No action will be taken at this time.
Event or Problem Description
Based on the information reported by the customer, a patient had an allergic reaction to the adhesive clear window on the drape.Ѕr the information received the patient is allergic to tegaderm.The patient was prescribed benadryl, zinc oxide cream and triamcinolone 0.1%.Patient was discharged to home post-op day three.

• Brand Name: C SECTION PACK (CSGRJ)602
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CARDINAL HEALTH FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 5959794
• Report Number: 1423537-2016-00047
• Device Sequence Number: 16318213
• Product Code: LRO
• UDI-Device Identifier: 10887488533629
• UDI-Public: 10887488533629
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2016

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
• Operator of Device: No Information
• Device Model Number: SMA7CCSGRK
• Device Catalogue Number: SMA7CCSGRK
• Device Lot Number: 392358
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2016
• Initial Report FDA Received Date: 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Weight: 59