MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL PI ULTRA TOUCH GLOVES; SURGICAL GLOVE

Model Number 41175

Device Problems Device Or Device Fragments Location Unknown (2590); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

No deviations were identified in the batch documentation.Visual examination of retained sample was found to be within specification.

Event Description

A hospital reported that a piece of glove tore off inside of patient during surgical procedure and could not be located.A picture of the box the complaint glove came from was provided.The hospital reported they retained the actual complaint glove.Request was made to provide a picture of the actual glove and additional information regarding the event.On (b)(6) 2016, additional information was received.The event occurred in association with a shoulder arthroscopy.The surgeon was double gloved.The underglove was not perforated.There was nothing unusual about the patient or procedure.In an effort to locate the torn piece of glove, irrigation, x-ray, endoscope and cat scan were performed.The missing piece was approx 2mm x 6mm and was first noticed as soon as the finger was removed from the patient.Multiple attempts have been made for additional information, however no additional information is available at the time of this report.

• Brand Name: BIOGEL PI ULTRA TOUCH GLOVES
• Type of Device: SURGICAL GLOVE
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer (Section G): MOLNLYCKE HEALTH CARE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer Contact: jamie bradshaw ; 5550 peachtree parkway; norcross, GA 30092 ; 4703759051
• MDR Report Key: 6031983
• MDR Text Key: 57557167
• Report Number: 3004763499-2016-00003
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 41175
• Device Lot Number: 15I187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other