CDH #29

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-30 for CDH #29 manufactured by Ethicon.

Event Text Entries

[2128] 5o year old admitted for low anterior resection for ca. Ethicon cdh 29 curved intraluminal stapler was introduced via the rectum by the surgeon under direction of the sales rep. As the instrument was twisted, as directed, as directed, the cone tip perforated the posterior wall of the bowel. The instrument was removed and taken by the rep. A hand sewn anastamosis was done. Patient discharged home after a seven day length of stayinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. 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: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3555
MDR Report Key3555
Date Received1992-12-30
Date of Report1992-12-10
Date of Event1992-10-27
Date Facility Aware1992-10-27
Report Date1992-12-10
Date Reported to Mfgr1992-10-27
Date Added to Maude1993-04-23
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 NameCDH #29
Product CodeFHM
Date Received1992-12-30
Lot NumberCL3ON
Device Expiration Date1996-07-01
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Implant FlagN
Device Sequence No1
Device Event Key3297
ManufacturerETHICON


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-12-30

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