MAUDE Adverse Event Report: CARDINAL HEALTH 200, INC T.E.D.; STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)

Model Number	7115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
**udi related data quality updates only** corrected section d1 brand name; corrected section d3 manufacturer name; corrected section d4 catalog number; corrected section g4 pma/510(k)number; corrected section h5 labeled for single use?.

• Brand Name: T.E.D.
• Common Device Name: STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
• Manufacturer (Section D): CARDINAL HEALTH 200, INC; 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
• Report Number: 3009211636-2023-00824
• Device Sequence Number: 12194991
• Product Code: DWL
• UDI-Device Identifier: 10192253015973
• UDI-Public: 10192253015973
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 10/02/2023; Not provided
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/17/2023; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown