MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NORTH MINOR PACK-LF

Catalog Number DYNJ0166780R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/03/2022

Event Type  Injury  

Event Description

According to the facility during a procedure an 18x18 lap sponge 'fell apart and had to be removed from the wound during surgery'.No additional information is available.

Manufacturer Narrative

According to the facility during a procedure an 18x18 lap sponge 'fell apart and had to be removed from the wound during surgery'.No additional information is available as the facility was unable to provide any further details.The sample is not available and is unable to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: NORTH MINOR PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13891768
• MDR Text Key: 287844601
• Report Number: 1423395-2022-00009
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10195327021559
• UDI-Public: 10195327021559
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ0166780R
• Device Lot Number: 21JMF304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other