MAUDE Adverse Event Report: MEDLINE MAJOR BREAST PACK / MEDLINE INDUSTRIES, LP - LAREDO MEDLINE MAJOR BREAST PACK; PLASTIC SURGERY AND ACCESSORIES KIT

Lot Number 23AB0917

Device Problems Particulates (1451); Device Fell (4014)

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

Event Date 04/04/2023

Event Type  malfunction  

Event Description

Pt undergoing a bilateral mastectomy with envisio localized sentinel lymph node biopsy, possible axillary dissection.A fluffy blob of blue fuzz almost 1 cm long was found in the incision.It came from either a blue towel or a lap sponge.Then, when the tech wet a lap, the blue radiopaque tag fell off.

• Brand Name: MEDLINE MAJOR BREAST PACK
• Type of Device: PLASTIC SURGERY AND ACCESSORIES KIT
• Manufacturer (Section D): MEDLINE MAJOR BREAST PACK / MEDLINE INDUSTRIES, LP - LAREDO; northfield IL 60093
• MDR Report Key: 16713753
• MDR Text Key: 313134721
• Report Number: MW5116500
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 23AB0917
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American