MAUDE Adverse Event Report: ANSELL SHAH ALAM SDN. BHD PERRY STYLE 42; LATEX POWDERED SURGICAL GLOVES

Catalog Number 5711102

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Reaction (2414)

Event Type  Injury  

Event Description

An mdr is being filed after our company learned that a doctor developed runny nose, and her staff developed itchiness and rash on hands after using our perry style 42 surgical gloves.

Manufacturer Narrative

(b)(4).Additional catalog number: 5711103.Additional lot numbers: 1205106121, 1204013821.

• Brand Name: PERRY STYLE 42
• Type of Device: LATEX POWDERED SURGICAL GLOVES
• Manufacturer (Section D): ANSELL SHAH ALAM SDN. BHD; selangor darul ehsan ; MY
• Manufacturer (Section G): ANSELL SHAH ALAM SDN. BHD; lot 16, persiaran perusahaan; selangor darul ehsan ; MY
• Manufacturer Contact: yeisa whaley ; 1635 industrial rd.; dothan, AL 36303
• MDR Report Key: 3674456
• MDR Text Key: 4237629
• Report Number: 1019632-2014-00004
• 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
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Catalogue Number: 5711102
• Device Lot Number: 1212044421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2014
• Distributor Facility Aware Date: 01/31/2014
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/04/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Patient Outcome(s): Other