MAUDE Adverse Event Report: ANSELL LANKA (PVT) LTD GAMMEX; SURGICAL GLOVE

Device Problem Cross Reactivity (1137)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/29/2016

Event Type  Injury  

Event Description

Fda received a voluntary report 03-11-2016 (report number mw5060897).User had contact dermatitis/auto eczematization due to accelerant used in gammex non latex gloves.Severe reaction involving hands, ears, upper extremity, weeping dermatitis/swelling.

Manufacturer Narrative

A review of the device history record for the subjectr glove (gammex non latex pi surgical glove) indicates no changes were made to the processes, and total water extractable levels for the last twelve months were within specification.No samples or lot number were returned for investigation; therefore, exact conclusion for allergic reaction could not be determined.

Event Description

Fda received a voluntary report 03-11-2016 (report number mw5060897).User had contact dermatitis/auto eczematization due to accekerant used in gammex non latex gloves.Severe reaction involving hands, ears, upper extremity, weeping dermatitis/swelling.

• Brand Name: GAMMEX
• Type of Device: SURGICAL GLOVE
• Manufacturer (Section D): ANSELL LANKA (PVT) LTD; biyagama export processing zon; biyagama gampaha, LK-11 ; CE LK-11
• MDR Report Key: 5616927
• MDR Text Key: 44010915
• Report Number: 1019632-2016-00004
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2016,06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 04/28/2016
• Distributor Facility Aware Date: 04/27/2016
• Event Location: Outpatient Treatment Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR