SURGICAL LASER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-01 for SURGICAL LASER manufactured by Sun Health Corp..

Event Text Entries

[20161866] This is a 76-yr-old white female who has a history of peripheral vascular disease. Pt complained of laser burns on left thigh after a laser in vascular surgery. When dr saw her she had one medium size and one large size full thickness burns on the medial aspect of the left thigh and one tiny one located on the scar of the left thigh in the groin area. Because the burns were infected, dr decided to do a debridement of the burns as outpt surgery, and then later on do the definitive repair. On outpt basis the pt was treated according with the cultures. On 5/15/91, under spinal anesthesia dr did debridement of the burns, large, medium and tiny one, and the tiny one was closed primarily with a nylon. The pt did well during surgery but she had problems awakening from the spinal anesthesia and blood pressure was kind of unsteady, so dr decided to admit her. She was placed on iv penicillin pending the culture taken. The following day the pt complained bitterly of pain on the right hip. Dr ordered hip ultrasound. Cultures came and dr placed her on erythromycin, ampicillin in accordance with the sensitivity. There were multiple organisms present. Dr stopped the iv penicillin. The wound was treated with wet to dry saline dressing, changed q3 hrs during the day. The pt recovered from the pain in the hip which was a bursitis and dr decided to keep the pt on iv antibiotics while the wound improved. As soon as the wound was in good condition, dr took her again to surgery. On 5/22/91, dr did a debridement, irrigation and secondary closure of the wounds on left thigh. Operation was done under epidural anesthesia and epidural catheter was left by the anesthesiologist for postop care of the pain. The erythromycin was before and discontinued after surery because the pt complained of nausea. She was kept on iv ampicillin only. She did very well after a few days; drains were removed and the wound looked okay. The wounds were healing well with no gross signs of infection. Dr put her on oral ampicillin. Today, after the pt is able to walk and also the pt is more comfortable and normal, the pt is discharged in good condition with the visiting rns to see her on a daily basis starting tomorrow for dressing changes. These are simple dressing changes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000164
MDR Report Key11311
Date Received1994-02-01
Date of Report1993-03-26
Date Added to Maude1994-02-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSURGICAL LASER
Product CodeLWX
Date Received1994-02-01
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key11311
ManufacturerSUN HEALTH CORP.
Manufacturer AddressSUN CITY AZ 85372 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-02-01

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