MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SDS MN BREAST PACK

Catalog Number DYNJ57719C

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "during a breast lumpectomy case, doctor found loose lap fiber in wound that she picked out with forceps." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.There was no serious injury originally reported related to this event.No sample returned for evaluation and lot number is unknown.Therefore, a root cause will be difficult if not impossible to determine.Due to the reported incident, medical intervention 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.

Event Description

It was reported, "during a breast lumpectomy case, doctor found loose lap fiber in wound that she picked out with forceps".

• Type of Device: SDS MN BREAST PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11596417
• MDR Text Key: 244393514
• Report Number: 1423395-2021-00015
• Device Sequence Number: 1
• Product Code: FTN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ57719C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• 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