COBAN 2 LITE LAYER COMPRESSION SYSTEM 2794

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2017-12-06 for COBAN 2 LITE LAYER COMPRESSION SYSTEM 2794 manufactured by 3m Health Care.

Event Text Entries

[94071820] Pt weight, ethnicity and race information was not supplied by reporter. Although pulmonary embolism occurs at a known rate postoperatively following joint replacement surgery, including knee arthroplasty, this was the 4th pulmonary embolism event reported to 3m from this study. This seems to be a slightly higher prevalence rate than expected but we do not know if it is statistically significant. 3m contacted the study investigators to obtain additional patient details regarding operative duration, patient comorbidities and medical history. No additional information has been received to date. (b)(4). There was no conclusive evidence that the occurrence of a pulmonary embolism was related to the use of 3m coban 2 lite layer compression system post total knee arthroplasty. 3m will continue to monitor complaints and trends for this type of report.
Patient Sequence No: 1, Text Type: N, H10


[94071821] An independent study investigator reported coban 2 lite layer compression system was applied to a (b)(6) female patient following a total knee arthroplasty. The patient experienced chest pain and shortness of breath on post op day 12. The patient was hospitalized and a ct scan confirmed the patient experienced a pulmonary embolism.
Patient Sequence No: 1, Text Type: D, B5


[114899105] 3m received a formal letter from the university of (b)(6) regarding their investigation of the four pulmonary embolisms that occurred within the investigator-initiated research study entitled "the use of 3m? Coban? 2 lite layer compression system post-total knee arthroplasty". The university (b)(6) consulted with two independent content experts to investigate the etiology of the pulmonary embolisms and to determine whether they were related to the study intervention, i. E. , the 3m? Coban? 2 lite layer compression system. In brief, the independent content experts reached consensus that the four pes were likely unrelated to the study intervention 3m? Coban? 2 lite layer compression system.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2110898-2017-00146
MDR Report Key7089114
Report SourceFOREIGN,HEALTH PROFESSIONAL,S
Date Received2017-12-06
Date of Report2018-03-27
Date of Event2017-11-04
Date Mfgr Received2017-11-07
Date Added to Maude2017-12-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS KAREN KRENIK, BSN
Manufacturer Street3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE
Manufacturer CityST. PAUL MN 55144
Manufacturer CountryUS
Manufacturer Postal55144
Manufacturer Phone6517333091
Manufacturer G1MANUFACTURING MEDICAL DEVICES
Manufacturer StreetEDISONSTRASSE 6 D-59157
Manufacturer CityKAMEN,
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOBAN 2 LITE LAYER COMPRESSION SYSTEM
Generic NameCOBAN 2 LITE LAYER COMPRESSION SYSTEM
Product CodeFQM
Date Received2017-12-06
Catalog Number2794
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer Address2510 CONWAY AVE ST. PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2017-12-06

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