MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE PREVENTION PLUS STERILE SURGICAL GOWN; GOWN, SURGICAL

Model Number DYNJP2306P

Device Problem Contamination (1120)

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

Event Date 01/27/2021

Event Type  malfunction  

Event Description

Sterile gown contained insect.

• Brand Name: MEDLINE PREVENTION PLUS STERILE SURGICAL GOWN
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 11250981
• MDR Text Key: 229601827
• Report Number: MW5099089
• Device Sequence Number: 1
• Product Code: FYA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJP2306P
• Device Catalogue Number: DYNJP2306P
• Device Lot Number: 20820080019K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1