MAUDE Adverse Event Report: HALYARD HEALTH HALYARD GOWN SURG NON-REINFORCED

Catalog Number 72888

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

Event Type  malfunction  

Event Description

(b)(6) gowns are having strike through in regard pack 880051, lot#1913532682 (ht0051).

• Brand Name: HALYARD GOWN SURG NON-REINFORCED
• Type of Device: HALYARD GOWN SURG NON-REINFORCED
• Manufacturer (Section D): HALYARD HEALTH; alpharetta GA
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4177303937
• MDR Report Key: 9813683
• MDR Text Key: 200814664
• Report Number: 3014527682-2020-00003
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1