EMS SEAMLESS ANTI-EMBOLISM ELASTIC STOCKINGS MDS 160744

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-06 for EMS SEAMLESS ANTI-EMBOLISM ELASTIC STOCKINGS MDS 160744 manufactured by Medline Industries.

Event Text Entries

[2043] Tigh hi ted stockings to left leg and knee hi to right leg were applied preoperative on 1/24/92. On 1/26/92, patient voiced complaints of pain to left foot. Both feet slightly edematous and tender to touch. Linear blister area noted on both feet, dorsal side mid arch up toward ankle approximately 10cms. Ted's were discontinued at this point. Initially felt as if patient may have some type of vascular problem. After diagnostic sufficient to explain the apparent symptoms in feet. Patient was treated with a foot cradle and started on antibiotics due to possible cermal gangrene. Shortly after incident on 2/1/92, a similar incident occurred with a 73 year old male patient with thigh hi ted's. At this point suspicion was directed to ted's. Patient was also measured a second time to assure correct ted's were used. Further evaluation involved surveying nurse managers if any problems had been detected with use of ted. On a couple occasions reports indicated that patients' dorsal area of foot were noted to be slightly redden at times and required ongoing inspection of feet and stimulation of circulation. Finally, two employees wore one thigh hi hose from medline and another thigh hi hose from another manufacturer to note for comparisions. The medline was a tighter fit especially behind knee and across foot. One employee experienced some redness above the knee area. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was multiple patient involvement. Number of patients involved: 2. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated, performance tests performed. Results of evaluation: design. Conclusion: other. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3864
• MDR Report Key: 3864
• Date Received: 1992-07-06
• Date of Report: 1992-02-10
• Date of Event: 1992-02-01
• Date Facility Aware: 1992-02-01
• Report Date: 1992-02-10
• Date Reported to Mfgr: 1992-02-10
• Date Added to Maude: 1993-05-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EMS SEAMLESS ANTI-EMBOLISM ELASTIC STOCKINGS
• Generic Name: TED HOSE
• Product Code: FQL
• Date Received: 1992-07-06
• Catalog Number: MDS 160744
• Lot Number: N/A
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3604
• Manufacturer: MEDLINE INDUSTRIES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-06