MAUDE Adverse Event Report: STRYKER INSTRUMENTS FLYTE, SURGICOOL; GOWN, SURGICAL

Model Number 0408841100

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 10/14/2019

Event Type  malfunction  

Event Description

Gowns were ripping apart during surgery.Axillary areas and chest as well.Only ref # provided; no lot # or packaging retained.Charges indicate 2 used of this size and 3 used of another size.Epic review: discharged day after surgery.Better than expected post-op course this first week; patient states feels great.

• Brand Name: FLYTE, SURGICOOL
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 9334661
• MDR Text Key: 166762806
• Report Number: 9334661
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0408841100
• Device Catalogue Number: 0408841100
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA