MAUDE Adverse Event Report: MEDLINE, SENSICARE MICRO SENSICARE MICRO SURGICAL GLOVE, SIZE 7

Lot Number 604840453560

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 08/26/2016

Event Type  Injury  

Event Description

Physician opened a sterile pair of size 7 sensicare micro surgical gloves (synthetic polyisoprene ), and found what appears to be a faint blood smudge on one of the gloves.Gloves and package given to director of materials management, who plans to contact manufacturer representative.

• Brand Name: SENSICARE MICRO SURGICAL GLOVE, SIZE 7
• Type of Device: SENSICARE MICRO SURGICAL GLOVE, SIZE 7
• Manufacturer (Section D): MEDLINE, SENSICARE MICRO
• MDR Report Key: 5917269
• MDR Text Key: 53699688
• Report Number: MW5064446
• Device Sequence Number: 1
• Product Code: KGO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 604840453560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention