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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC ORIGO; CATHETER, STRAIGHT
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WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC ORIGO; CATHETER, STRAIGHT Back to Search Results
Model Number 44312
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No samples were returned why no investigation of the products could be performed.The review of the batch documentation showed no deviations.Without the benefit of examination and testing, the manufacturer is precluded from commenting on the condition of the device or the cause of the occurrence.Should the device or additional information be received, a follow up report will be filed.
 
Event or Problem Description
According to the reporter, there was no water sachet in the package, and the patient tried to use the catheter anyhow.The patient claimed he was hurt and experienced bleeding, but recovered without sequelae.
 
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Brand Name
LOFRIC ORIGO
Common Device Name
CATHETER, STRAIGHT
Manufacturer (Section D)
WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
aminogatan 1
p.o. box 14
mölndal, sweden SE-43 121
SW  SE-43121
MDR Report Key7171128
Report Number3009632672-2018-00001
Device Sequence Number1016314
Product Code EZD
UDI-Device Identifier07392532158292
UDI-Public07392532158292
Combination Product (Y/N)N
PMA/510(K) Number
K122078
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Model Number44312
Device Catalogue Number44312
Device Lot Number407849
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/13/2017
Initial Report FDA Received Date01/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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