MAUDE Adverse Event Report: COVIDIEN T.E.D.; STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)

Model Number 7115

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Injury (2348)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports during pancreatic surgery, peroneal paralysis occurred.The compartment syndrome has occurred before, so during surgery, observation was adequate even after entering the icu, although ted hadn't been taken off.

• Brand Name: T.E.D.
• Type of Device: STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
• Manufacturer (Section D): COVIDIEN; edifico
• Manufacturer (Section G): COVIDIEN; edifico
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7646953
• MDR Text Key: 112631957
• Report Number: 3009211636-2018-00219
• Device Sequence Number: 1
• Product Code: DWL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7115
• Device Catalogue Number: 7115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other