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

Model Number PB37LVJOD

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

Patient Problems Rash (2033); Reaction (2414)

Event Date 06/27/2016

Event Type  Injury  

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 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
• Type of Device: 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
• Manufacturer (Section G): CONVERTORS DE MEXICO, S.A. DE C.V.; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 5957478
• MDR Text Key: 54993241
• Report Number: 1423537-2016-00046
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10887488405223
• UDI-Public: 10887488405223
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PB37LVJOD
• Device Catalogue Number: PB37LVJOD
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/24/2016
• Date Manufacturer Received: 08/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 78