MAUDE Adverse Event Report: CONVERTORS DE MEXICO, S.A. DE C.V. KIT,LAVH (VJOC )829; GENERAL SURGERY TRAY (KIT)

Model Number	PB37LVJOD
Health Effect - Clinical Codes	Rash (2033); Reaction (2414)
Date of Event	06/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this investigation no lot number or sample were provided.Without the lot number we were unable to review the device history record to determine if any deviations took place during the manufacturing process for the given product number.The process is in compliance with applicable standard production method (spm).It was verified that all operators are certified in their respective operations.Without the sample or lot number the root cause could not be determined.No action will be taken at this time.  we will continue to watch for trends based on this type of report.
Event or Problem Description
Based on the customer information submitted, the patient had a significant reaction to the drape, (b)(4).Per the customer the patient is allergic to adhesive (band aids, tape etc.).After surgery she broke out in a rash.The patient was prescribed steroids and a cream.

• Brand Name: KIT,LAVH (VJOC )829
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CONVERTORS DE MEXICO, S.A. DE C.V.; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 5957478
• Report Number: 1423537-2016-00046
• Device Sequence Number: 16318210
• Product Code: LRO
• UDI-Device Identifier: 10887488405223
• UDI-Public: 10887488405223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2016

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: PB37LVJOD
• Device Catalogue Number: PB37LVJOD
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2016
• Initial Report FDA Received Date: 09/16/2016
• 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: 43 YR
• Patient Weight: 78