ACE/GAUZE CADT PLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-26 for ACE/GAUZE CADT PLASTER manufactured by .

Event Text Entries

[15560080] "dr rushed to place unk arthodesis, over caprs, let kid dress it, 5 minutes per report, cadt drooped,, ten days later found and told kid to fix it an left --- wrapped tight elbow to fingers then placed cleaner bottle, on tray wet plaster wrap on top re set wrist into hi arc, wrapped tightly with ace type bandages, as pain rose to intolerable, returned to clinic xrayed reported forearm not broke remedial pain toughen up. Ten days later unwrapped dead hand, cherry to brown, signed form as healing nicely, very irregular signature. Eight months therapy 3 times week, confronted surgeon and wc dr, resigned, refused 2nd opinion, went to baylor to remove hand, r+r plate 4 screws trash debris loose screws not 8 / had visitor on surgery record, waited 6 hrs to start, graphoanalysis refers dr lie on reports 4 occasions / 1 being problem and extent' informing pt, on procedure to be used, tighten ligament, vs arthodesis. Remove scaphoid, who did surgery, that was set wrong, 90 off ideal, after fusion, and re set. Ten days later, that ligature had occurred, healing nicely, struck pt when shoulder pain was referred to him by therapist foot pain at noise. " in early 2005, entered therapy, cleansed for week, then exercises to no avail 8 month. Dates of use: 2004 - 2005, 12 months. Diagnosis or reason for use: carpal instability, surgical dressing, cast. Event abated after use stopped or dose reduced? : yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5011233
MDR Report Key1395075
Date Received2009-05-26
Date of Report2009-05-26
Date Added to Maude2009-06-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameACE/GAUZE CADT PLASTER
Generic NameACE/GAUZE CADT PLASTER
Product CodeLGF
Date Received2009-05-26
OperatorOTHER
Device AvailabilityY
Device Sequence No1
Device Event Key0

Device Sequence Number: 2

Brand NameSPIDER PLATE AND ACCESSORIES
Generic NameSPIDER PLATE AND ACCESSORIES
Product CodeHRS
Date Received2009-05-26
OperatorOTHER
Device AvailabilityY
Device Sequence No2
Device Event Key0

Device Sequence Number: 3

Brand Name4 PAIR 10, 12, 14 SCREWS
Generic Name4 PAIR 10, 12, 14 SCREWS
Product CodeHWC
Date Received2009-05-26
OperatorOTHER
Device AvailabilityY
Device Sequence No3
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2009-05-26

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