MAUDE Adverse Event Report: COVIDIEN

Model Number UNKNOWN TED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

Submit date: 05/17/2017.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer states that a patient from the ambulatory ward slid/fell while walking with ted stockings and no shoes.She fell on her bottom and knocked her head on the bed.She had no bruises but complained of shoulder pain.She was hospitalized and imagery showed a fracture and a vertebral compression.She then had a kyphoplasty surgery due to the fracture and vertebral compression.The patient had no previous history and came the same day resection of an axillary nodule.The customer further reports that the surgery went well.The surgery following the event added 5 days of hospitalization.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

No sample or picture was provided by the customer for evaluation.Additionally, device history record could not be reviewed since there was no lot number provided.Potential root causes could be related to improper use of product by the customer and material used to manufacture the product.This defect has not been confirmed, since there is no enough evidence provided by the customer such as sample, lot number, item code or picture.As per the manufacturing process, all controls related to the acceptance of the product are in place and personnel is appropriately trained in order to prevent getting nonconforming product from the manufacturing process.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6572692
• MDR Text Key: 75361108
• Report Number: 3009211636-2017-05110
• Device Sequence Number: 1
• Product Code: DWL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN TED
• Device Catalogue Number: UNKNOWN TED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 57