MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL PI INDICATOR UNDERGLOVE 6.5; SURGEON GLOVES

Model Number 41665

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2022

Event Type  Injury  

Event Description

Report received of a torn glove.(b)(6) 2022: follow up information stated an emergency department physician performed a chest tube insertion on a patient.Physician created a track for the chest tube using a finger.When physician removed finger, the glove tip (from just below middle knuckle) was missing.Unable to locate glove tip.Patient transferred to higher level of care and thoracic surgeon for glove tip removal.(b)(6) 2022: follow up information stated no overglove was used during the chest tube insertion.Thoracic surgeon successfully removed a 7cm blue glove piece.The patient was discharged from the hospital and has returned for routine follow up and a chest x-ray for the originating reason the patient was in the emergency department.No additional complications reported related to the torn glove piece.(b)(6) 2022: follow up information stated (b)(6) patient with recurrent right spontaneous pneumothorax was treated at the emergency department on (b)(6) 2022.A large bore chest tube was placed and a portion of the providers glove was lost inside the chest.Patient transferred for management.Right vats with removal of glove fragment and talc pleurodesis was performed on (b)(6) 2022.Procedure was well-tolerated without complications.Operative findings included a large hematoma in the region of previous chest tube due to insertion through pectoralis muscles as well as injury to the lower lobe secondary to ct insertion.Additionally, a large piece of blue glove was identified and was removed and sent to pathology.Pathology confirmed foreign body right lung removal consisted of a finger tip of a blue glove measuring 7.0 cm in length x 2.3 cm in diameter with multiple defects.There are also scant tan-brown fibrous tissue adhered on the glove.Chest tube was placed intra-operatively and removed 72h post-op.Discharged on (b)(6) 2022.

• Brand Name: BIOGEL PI INDICATOR UNDERGLOVE 6.5
• 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: 14323378
• MDR Text Key: 294660649
• Report Number: 3004763499-2022-00001
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 41665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 94 KG