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 Number3864
MDR Report Key3864
Date Received1992-07-06
Date of Report1992-02-10
Date of Event1992-02-01
Date Facility Aware1992-02-01
Report Date1992-02-10
Date Reported to Mfgr1992-02-10
Date Added to Maude1993-05-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEMS SEAMLESS ANTI-EMBOLISM ELASTIC STOCKINGS
Generic NameTED HOSE
Product CodeFQL
Date Received1992-07-06
Catalog NumberMDS 160744
Lot NumberN/A
OperatorOTHER CAREGIVERS
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key3604
ManufacturerMEDLINE INDUSTRIES


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-07-06

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