MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TOWEL,OR,DSP,ST,BLUE,STD,6/PK,12PK/CS

Catalog Number MDT2168286

Device Problems Contamination (1120); Device Operates Differently Than Expected (2913)

Patient Problem Post Operative Wound Infection (2446)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the blue operating room towels "were linting in chunks and linting may have caused an infection." no information was provided by the reporting facility whether this is an actual diagnosis and what treatment was required as a result of this incident.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause cannot be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the blue operating room towels were "linting in chunks and may have caused an infection.".

• Type of Device: TOWEL,OR,DSP,ST,BLUE,STD,6/PK,12PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 7542472
• MDR Text Key: 109223748
• Report Number: 1417592-2018-00042
• Device Sequence Number: 1
• Product Code: FRL
• UDI-Device Identifier: 10080196282746
• UDI-Public: 10080196282746
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MDT2168286
• Device Lot Number: 26017120008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other