MAUDE Adverse Event Report: MOLNLYCKE HEALTHCARE BIOGEL SURGEONS; SURGEONS GLOVES

Model Number 30475

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

The exact model and lot information are unknown as the device, including packaging , were discarded by the reporting facility and the identifying information was not recorded.

Event Description

Tip of glove, approx 1cm x 2cm, straw colored, was identified in patient's hip wound during re-exploration of hip due to hematoma.Tip of glove removed from wound.Potential infection noted.Thorough wound irrigation performed.Exact model of glove unknown.Request has been made for additional information, however no further information is available at the time of this report.

• Brand Name: BIOGEL SURGEONS
• Type of Device: SURGEONS GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer (Section G): MOLNLYCKE HEALTHCARE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer Contact: pat strahl ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 4703750171
• MDR Report Key: 7775814
• MDR Text Key: 116857631
• Report Number: 3004763499-2018-00003
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• PMA/PMN Number: K053441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2018

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 Model Number: 30475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/12/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention