HANDLYSEAL FDR4367

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2002-09-26 for HANDLYSEAL FDR4367 manufactured by Conroy Medical Ab.

Event Text Entries

[16784292] The operator was having difficulties sealing the tubing on pall blood bags. It was believed by the staff at the center that if pressure was applied to the sealer head during the sealing process the quality of the seal would improve. The operator was using a forefinger to apply pressure. The operator's forefinger slipped from the sealer head and came into close proximity of the electrodes. The finger was burned and the center mgr stated the incident was accompanied by the smell of burning flesh. The operator was given first aid. A nurse examined the wound and reported that it was deep and consistent with an electrical burn.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1420141-2002-00056
MDR Report Key420425
Report Source01,05
Date Received2002-09-26
Date of Report2002-08-27
Date of Event2002-08-09
Date Mfgr Received2002-08-27
Date Added to Maude2002-10-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactDEBBIE LAHR, MGR
Manufacturer StreetRT 120 AND WILSON RD
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone8472704695
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionMA
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameHANDLYSEAL
Generic NameSEALER
Product CodeKSD
Date Received2002-09-26
Model NumberNA
Catalog NumberFDR4367
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key409481
ManufacturerCONROY MEDICAL AB
Manufacturer AddressVALHALLAVAGEN 1 UPPL. VASBY * S-194 63
Baseline Brand NameHANDYSEAL
Baseline Generic NameHANDYSEAL
Baseline Model NoFDR4367
Baseline Catalog NoFDR4367
Baseline IDSEALER
Baseline Device FamilySEALER
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-09-26

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