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

Model Number 30490

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/19/2018

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.A small piece of the found material was returned inside a sample bottle tube for analysis, however analysis could not be conducted due to the limited size and lack of identifying product/batch information.

Event Description

A piece of material, believed to be from a surgical glove, was found in a female patient's bed pan when it was emptied.The patient mentioned the urination had been painful immediately preceding discovery of the piece of material in the bedpan.The patient believes she passed the material during urination.The patient was 1 day post op from emergency cystoscopy, left retrograde and stenting.The size of the material was 1.5 cm long and 0.5 cm wide.Additional information received on 17sep2018 stated the patient was fine.She had to have another cystoscopy but it was not related to the piece of material being found.No additional information is available or expected.

• 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 ; 4702507982
• MDR Report Key: 7885735
• MDR Text Key: 120570638
• Report Number: 3004763499-2018-00004
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other