MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL PI MICRO INDICATOR GLOVE; SURGEON GLOVES

Model Number 48555

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Bacterial Infection (1735); Foreign Body In Patient (2687)

Event Date 06/17/2022

Event Type  Injury  

Event Description

A report was received that a patient underwent an emergency surgical revision due to an infected hip implant.During the revision surgery, a rubber-like 2x4 cm foreign body was removed.The foreign body was thought to be a piece of surgical glove used in the initial hip replacement surgery.There was no report of a glove failure or tear in the original surgery which occurred approximately one year ago.Follow up information received 21 jul 2022 stated that a left artificial head insertion was performed on (b)(6) 2021 (left femoral neck fracture).On (b)(6) 2022, the patient was hospitalized due to purulent arthritis curettage (left hip prosthesis infection).During the revision surgery, the torn and curled foreign body was removed from the proximal part of the anterior edge of the gluteus medius muscle.No additional information has been made available at the time of this report.

• Brand Name: BIOGEL PI MICRO INDICATOR GLOVE
• Type of Device: SURGEON GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; 5445 triangle parkway; suite 400; peachtree corners GA 30092
• Manufacturer (Section G): MOLNLYCKE HEALTH CARE; 5445 triangle parkway; suite 400; peachtree corners GA 30092
• Manufacturer Contact: pat strahl ; 5445 triangle parkway; suite 400; peachtree corners, GA 30092 ; 4042700985
• MDR Report Key: 15136486
• MDR Text Key: 296943141
• Report Number: 3004763499-2022-00006
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian