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 Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/23/2019

Event Type  malfunction  

Event Description

It was reported that at the user facility, the toga is ripping and the plastic front panel is peeling away.Additional information has been requested from the user facility.

Event Description

It was reported that at the user facility, the toga is ripping and the plastic front panel is peeling away.Additional information has been requested from the user facility.

Manufacturer Narrative

The device was returned for evaluation.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: 8709754
• MDR Text Key: 148415025
• Report Number: 0001811755-2019-02074
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1