MAUDE Adverse Event Report: CONVERTORS DE MEXICO, S.A. DE C.V. HAND PACK (HDFLA)878; GENERAL SURGERY TRAY (KIT)

Model Number	SOPDKHDFLB
Health Effect - Clinical Codes	Itching Sensation (1943); Reaction (2414)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this investigation no lot number was provided, therefore the device history record could not be reviewed.  as sample was not available for further investigation, the failure could not be confirmed and the root cause could not be determined.  the complaint information was informed to the relevant sectors for their awareness.There is no additional action taken at this time, however, we will continue to monitor the trend of this type of incident.
Event or Problem Description
Based on the report received a tech had a reaction to the set up gown (90380nc).Tech was prescibed a 10-day course of dexamethasone and has been using own aloe/vitamin e cream for itching.
Additional Manufacturer Narrative
The device history record could not be verified as lot number was not provided. review of the complaint history indicated this as the first reported incident for gown 90380nc.As no sample was provided, further investigation could not be conducted and the root cause could not be determined from this investigation.We will continue to monitor the trend for this type of incident and taken action if required.

• Brand Name: HAND PACK (HDFLA)878
• 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: 6305439
• Report Number: 1423537-2017-00071
• Device Sequence Number: 759257
• Product Code: LRO
• UDI-Device Identifier: 10887488478753
• UDI-Public: 10887488478753
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2017

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: Other
• Device Model Number: SOPDKHDFLB
• Device Catalogue Number: SOPDKHDFLB
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 03/02/2017
• 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: 70 YR
• Patient Weight: 114