MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; GOWN, SURGICAL

Catalog Number UNK_INS

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

Not returned.

Event Description

It was reported that at the user facility, the toga is tearing.Additional information has been requested from the user facility.

Event Description

It was reported that at the user facility, the toga is tearing.Multiple attempts were made to obtain additional information.The user facility was not able to provide any further information regarding the reported event.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8832121
• MDR Text Key: 152502908
• Report Number: 0001811755-2019-02571
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1