ADAPTOSIZE UNKNOWN E1056D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-25 for ADAPTOSIZE UNKNOWN E1056D manufactured by Tlk Industries, Inc..

Event Text Entries

[18953127] In the course of developing ultrasound films in accordance with facility instruction and direction, the lead film drawer suddenly and unexpectedly slammed on plaintiff's hand. Plaintiff sustained injury to her left hand, in the form of an amputation of a portion of her ring finger, paralysis, impairment and disfigurement. The film bin accommodates cartons of x-ray film for storage in a dark room to protect against exposure. The film bin is designed to be used by x-ray and ultrasound tech in a hosp dark room. The film bin holds film boxes for developing x-ray and ultrasound films. When the film bin is opened with its handle to the fully open position, it is supposed to remain open until closed with its handle. The construction of the bin prevents films from being exposed. The film bin was defective and unsafe for its intended purposes at the time it left the control of distributor. The design permitted the film bin to suddenly and unexpectedly slam closed due to the absence of any sort of catch or stop to prohibit the drawer from slamming closed. A safer alternative design existed at the time the product was mfg. The safer alternative design would have prevented or significantly reduced the risk of the plaintiff's injuries, without substantially impairing the product's utility. Furthermore, the safer alternative design was economically and technologically feasible at the time the product left the control of distributor application of existing or reasonably achievable scientific knowledge. There was no warning that the drawer could unexpectedly and suddenly slam. (*)
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2126677-1996-00004
MDR Report Key33114
Date Received1996-04-25
Date of Report1996-04-11
Date of Event1994-03-09
Date Facility Aware1996-04-02
Report Date1996-04-11
Date Reported to FDA1996-04-11
Date Reported to Mfgr1996-04-11
Date Added to Maude1996-05-28
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameADAPTOSIZE
Generic NameMETAL FILM STORAGE BIN
Product CodeIXA
Date Received1996-04-25
Model NumberUNKNOWN
Catalog NumberE1056D
Lot NumberUNKNOWN
ID NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key34433
ManufacturerTLK INDUSTRIES, INC.
Manufacturer Address500 SOUTH HICKS RD PALATINE IL 60067 US


Patients

Patient NumberTreatmentOutcomeDate
10 1996-04-25

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