MAUDE Adverse Event Report: DUKAL CORPORATION LUBRICANT, WATER SOLUBLE, TUBE, 2 OZ., 1/PACK; LUBRICANT, PATIENT

Model Number	31-704
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Granuloma (1876)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An end consumer reported a medwatch (#mw5114846) reporting, "sterile lubricant used during liposuction procedure contains carbomer polymer which caused foreign body reaction and impaired wound healing of liposuction sites with granulomas." a supplier corrective action request (scar) has been sent to dukal corporation.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is concluded from the investigation.
Event or Problem Description
Sterile lubricant used during liposuction procedure contains carbomer polymer which caused foreign body reaction and impaired wound healing of liposuction sites with granulomas.
Additional Manufacturer Narrative
The sample was returned to deroyal industries on (b)(6) 2023 for evaluation.A supplier corrective action request (scar) was issued to the lubricant supplier (b)(4).(b)(4) reviewed complaint history for the item and factory over the part two years and found no previous incidents for this issue.Batch records were also reviewed for the lot of the complaint sample.No abnormalities or changes to operation procedure were found.Labeling and biocompatibility were reviewed.The product passed biocompatibility testing.The ingredient that was stated to cause the reaction, carbomer, is listed on the label with no changes in the formulation.The complaint sample was reviewed.The product was free from defects and within specifications.Root cause: no problem found.Because there were no abnormalities within the batch records or samples, (b)(4) did not take any corrective or preventative actions.(b)(4) will continue to monitor for trends and/or reoccurrence.Deroyal reviewed (b)(4) cases or purchase orders and found no issues.Between (b)(6) 2021 to (b)(6) 2023, deroyal has sold (b)(4) cases of (b)(4).In this same time period (b)(4) complaints were received.This equates to a sales ratio (b)(4).Deroyal will also continue to monitor for trends.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: LUBRICANT, WATER SOLUBLE, TUBE, 2 OZ., 1/PACK
• Common Device Name: LUBRICANT, PATIENT
• Manufacturer (Section D): DUKAL CORPORATION; 2 fleetwood court; ronkonkoma NY 11779
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19929647
• Report Number: 1060680-2023-00001
• Device Sequence Number: 14143352
• Product Code: KMJ
• UDI-Device Identifier: 00749756028028
• UDI-Public: 00749756028028
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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 Model Number: 31-704
• Device Lot Number: 55912082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown