MAUDE Adverse Event Report: ANSELL LANKA (PVT) LTD GAMMEX NON LATEX SURGEON'S GLOVE; SURGEONS GLOVE

Catalog Number 8514

Device Problem Cross Reactivity (1137)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/27/2017

Event Type  Injury  

Event Description

On (b)(6) 2017 surgical technologist emailed indicates that she has a pre-existing sensitization to certain accelerators in use for certain surgical gloves.User was provided the gammex surgical gloves for three weeks and has been experiencing severe irritation on hands.User took a round of steroids which did not alleviate the irritation.User has stopped using the particular gloves and is using a cotton under glove liner which has allowed the irritation to abate.User is inquiring to possible use of accelerators for the product.

Manufacturer Narrative

10/12/2017 - a review of the batch record indicates that the product was compounded according to specification.No product contamination was found in reviewing samples and batch record.A test of the product from the lot in question was done to determine the presense of accelerators and antioxidant residues.Results of the evaluation indicate that no accelerators were detected and the antioxidants used in the formulation were present as expected.No root cause can be determined and no further action to be taken.

Event Description

(b)(6) 2017 surgical technologist emailed inidicates that she has a pre-existing sensitization to certain accelerators in use for certain surgical gloves.User was provided the gammex surgical gloves for three weeks and has been experiencing severe irritation on hands.User took a round of steriods which did not alleviate the irritation.User has stopped using the particular gloves asnd is using a cotton under glove liner which has allowed the irritation to abate.User is inquiring to possible use of accelerators for the product.

• Brand Name: GAMMEX NON LATEX SURGEON'S GLOVE
• Type of Device: SURGEONS GLOVE
• Manufacturer (Section D): ANSELL LANKA (PVT) LTD; biyagama export processing zon; biyagama gampaha, LK-11 ; CE LK-11
• MDR Report Key: 6721670
• MDR Text Key: 80310713
• Report Number: 1019632-2017-00010
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2017,10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 8514
• Device Lot Number: 1701056805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2017
• Distributor Facility Aware Date: 06/27/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR