MAUDE Adverse Event Report: BAUSCH + LOMB UNKNOWN PRODUCT

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/01/2023

Event Type  Injury  

Event Description

The user facility in netherlands reported during endo coagulation heavy bleeding occurred.The patient had permanent damage after the incident.Additional information was requested with no response at the time of this report.

Manufacturer Narrative

The serial number nor a lot number was provided; therefore, the sterilization and lot history records could not be reviewed.Additional information has been requested with no response.This investigation is ongoing.

Manufacturer Narrative

Additional information: the product was discarded.

Event Description

Additional information: all the patient information has been kept private.It was noted, this was a human failure not a machine failure to their understanding.

Manufacturer Narrative

Additional information: d1 d2 d4.G4 the complaint sample (b)(4) bipolar eraser was not returned for investigation and discarded by the customer.Photos of the sample were not provided.Therefore, the alleged issue could not be verified and the root cause could not be determined.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: UNKNOWN PRODUCT
• Type of Device: UNKNOWN PRODUCT
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB GMBH; im schuhmachergewann 4; heidelberg MO 69123 ; GM 69123
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17637621
• MDR Text Key: 322136488
• Report Number: 0001920664-2023-70081
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K882802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2023
• 2 Devices were Involved in the Event: 1 2

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/25/2023; 11/09/2023
• 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): Required Intervention