MAUDE Adverse Event Report: SHIJIAZHUANG HONGRAY GROUP CO., LTD. MICRO-TOUCH ELITE; VINYL EXAMINATION GLOVES

Catalog Number 3092

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Type  Injury  

Event Description

Our customer informed us that a clinician with known latex allergy developed severe allergic reaction after using our micro-touch elite powder free examination glove.

Manufacturer Narrative

(b)(4).

• Brand Name: MICRO-TOUCH ELITE
• Type of Device: VINYL EXAMINATION GLOVES
• Manufacturer (Section D): SHIJIAZHUANG HONGRAY GROUP CO., LTD.; shijiazhuang city, hebei province ; CH
• Manufacturer (Section G): SHIJIAZHUANG HONGRAY GROUP CO., LTD
• Manufacturer Contact: tammy mcgriff ; 1635 industrial rd.; dothan, AL 36303 ; 3346152566
• MDR Report Key: 3839419
• MDR Text Key: 4618148
• Report Number: 1019632-2014-00008
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3092
• Device Lot Number: 11117692DF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2014
• Distributor Facility Aware Date: 08/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2014
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1