MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP; PLASTIC PACK

Catalog Number DYNJ59359B

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

It was reported, that a patient experienced linting of the blue or towels during the middle of a liposuction/tummy tuck procedure.Reporter stated that the towels were inspected prior to the start of the procedure and no lint was identified at that time.It was reported that the lint was removed from patient's hip with a forceps, and all blue towels were throw away at that time.No serious injury or follow up medical care was reported related to the customer reported issue.The patient was under general anesthesia at the time of the incident, however no additional medication was required.There was no report of any adverse patient consequence, no effect on the patient's stability, and no additional medical intervention required as a result of the incident.Due to the reported incident and in an abundance of caution, a med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.

Event Description

It was reported, that a patient experienced linting of the blue or towels during the middle of a procedure requiring removal of the lint from the hip with forceps.

• Type of Device: PLASTIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• MDR Report Key: 12708921
• MDR Text Key: 281219789
• Report Number: 1423395-2021-00046
• Device Sequence Number: 1
• Product Code: FTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ59359B
• Device Lot Number: 21EBB214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 90