MAUDE Adverse Event Report: CARESTREAM HEALTH INC CS 2100 INTRAORAL X-RAY SYSTEM

Device Problem Break (1069)

Patient Problem Suture Abrasion (2497)

Event Date 10/06/2014

Event Type  Injury  

Manufacturer Narrative

This mdr is retrospectively being submitted after an evaluation of an event that occurred on (b)(6) 2014 which resulted in a patient injury.The defect that is associated with this event(s) was determined reportable as a class ii recall under z-1127-2014.

Event Description

The patient was injured on the face and received 5 sttiches.

• Brand Name: CS 2100 INTRAORAL X-RAY SYSTEM
• Type of Device: CS 2100
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH FRANCE; 1 rue gallilee; noisy-le-grand, 93192 ; FR 93192
• Manufacturer Contact: lee millward ; 51 abingdon road; bramhall, stockport SK7 3-EZ ; UK SK7 3EZ ; 78417373
• MDR Report Key: 6451327
• MDR Text Key: 71461445
• Report Number: 8020825-2017-00006
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: No
• 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