MAUDE Adverse Event Report: R82 A/S CROCODILE

Model Number SIZE 2

Device Problem Device Slipped (1584)

Patient Problem Sensitivity of Teeth (2427)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

A child was in a crocodile 2 when the seat failed to hold in place.The child chipped a tooth.

Manufacturer Narrative

(b)(4) is waiting for the product to be returned for eval.

• Brand Name: CROCODILE
• Type of Device: CROCODILE
• Manufacturer (Section D): R82 A/S; parallelvej 3; gedved 8751 ; DA 8751
• Manufacturer Contact: kent rasmussen ; parallelvej 3; gedved 8751 ; DA 8751 ; 579685888
• MDR Report Key: 4495617
• MDR Text Key: 5334113
• Report Number: 3001657382-2014-00011
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SIZE 2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2015
• Distributor Facility Aware Date: 12/17/2014
• Event Location: Home
• Date Report to Manufacturer: 12/17/2014
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other