MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PACKAGING, FORMULA SHAVER (HAND CONTROL); BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 0375704500

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that patient was burned.

Manufacturer Narrative

Canceling as duplicate of mfr report# 0002936485-2017-00316.Please note date of event was reported as "approximate" under both complaints.

Event Description

It was reported that patient was burned.

• Brand Name: PACKAGING, FORMULA SHAVER (HAND CONTROL)
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6472066
• MDR Text Key: 72109287
• Report Number: 0002936485-2017-00350
• Device Sequence Number: 0
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375704500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other