MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS CORD; DENTAL OPERATIVE UNIT AND ACCESSORIES.

Catalog Number 5100004000

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 04/03/2019

Event Type  malfunction  

Event Description

The user facility reported that the device overheated during the procedure and the patient received a 2cm burn with blister on the lip.The burn was treated with silvadene.There were no other adverse consequences regarding the event.

Manufacturer Narrative

Device not returned.

Event Description

The user facility reported that the device overheated during the procedure and the patient received a 2cm burn with blister on the lip.The burn was treated with silvadene.There were no other adverse consequences regarding the event.

• Brand Name: TPS CORD
• Type of Device: DENTAL OPERATIVE UNIT AND ACCESSORIES.
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8557302
• MDR Text Key: 143308485
• Report Number: 0001811755-2019-01539
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540970275
• UDI-Public: 04546540970275
• Combination Product (y/n): N
• PMA/PMN Number: K032117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5100004000
• Device Lot Number: 17300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1