MAUDE Adverse Event Report: CARDINAL HEALTH 7115 TED STKG NYLON MEDIUM; STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)

Model Number 7115

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

Patient Problem Nerve Damage (1979)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that peroneal nerve palsy occurred during use of ted surgical stockings.Ted was put on the patient for total knee arthroplasty.Later, the patient complained of numbness, and the physician who saw the patient diagnosed them as having peroneal nerve palsy.Additional information received on 02oct2023 stated that the patient has drop foot and poor dorsiflexion due to this incident.The patient is currently taking physical therapy.The numbness has decreased now.It is unknown how long the numbness stayed.No other symptoms were experienced.

Manufacturer Narrative

A sample was not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: 7115 TED STKG NYLON MEDIUM
• Type of Device: STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17865213
• MDR Text Key: 324877921
• Report Number: 3009211636-2023-00824
• Device Sequence Number: 1
• Product Code: DWL
• UDI-Device Identifier: 10192253015973
• UDI-Public: 10192253015973
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 7115
• Device Catalogue Number: 7115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention