MAUDE Adverse Event Report: ANSELL LANKA (PVT) LTD ENCORE LATEX MICRO SURGICAL GLOVE; SURGEON'S GLVOE

Model Number SIZE 7

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem Inflammation (1932)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Doctor called inquiring about the product has silicone as a component of the glove or packaging of the encore latex micro surgical glove.The glove is made with a silicone component to which the doctor reported patients started to develop corneal inflammation after using the new encore latex micro surgical glove during a lasik surgical procedure.Doctor indicated that he did not experience this issue previously.

Manufacturer Narrative

(b)(4).On 10/19/2016 a biological assessment of retain sample in which a surface analysis was conducted demonstrated that there is insufficient silicone presence to elicit a biological response and it is unlikely tha the cause of the episode of diffuse lamer keratitis (dlk) reported by the complaint is related to silicone contamination from the ansell microptic glove.According to the findings of the biological assessment report , the most likely cause is bacterial endotoxins from inadequately cleaned sterilizers.A review of the device history record indicates that the product was manufactured and released per specification.

Event Description

Doctor called inquiring about the product has silicone as a component of the glove or packaging of the encore latex micro surgical glove.The glove is made with a silicone component to which the doctor reported patients started to develop corneal inflammation after using the new encore latex micro surgical glove during a lasik surgical procedure.Doctor indicated that he did not experience this issue previously.

• Brand Name: ENCORE LATEX MICRO SURGICAL GLOVE
• Type of Device: SURGEON'S GLVOE
• Manufacturer (Section D): ANSELL LANKA (PVT) LTD; biyagama export processing zon; biyagama gampaha, LK-11 ; CE LK-11
• MDR Report Key: 5886623
• MDR Text Key: 52449851
• Report Number: 1019632-2016-00007
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2016,10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: SIZE 7
• Device Lot Number: 1602046405
• 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: 08/18/2016
• Distributor Facility Aware Date: 08/15/2016
• Device Age: 6 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/18/2016
• 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: 45 YR