MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 ZIPPER TOGA, L/XL; GOWN, SURGICAL

Catalog Number 0400820000

Device Problems Material Separation (1562); Torn Material (3024); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 05/03/2018

Event Type  malfunction  

Event Description

It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.

Manufacturer Narrative

Device evaluation: device was not returned.

Event Description

It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.

• Brand Name: T4 ZIPPER TOGA, L/XL
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7562447
• MDR Text Key: 109837398
• Report Number: 0001811755-2018-01037
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K070078
• 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,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0400820000
• Device Lot Number: 17082174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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