MED HOWMEDICA BONE PLUG 1PK 6215-5-011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-04-16 for MED HOWMEDICA BONE PLUG 1PK 6215-5-011 manufactured by Howmedica, Inc..

Event Text Entries

[17639938] Summary of evaluation: the evaluation results indicated that the event was attributed to a less than optimum design of the inner package envelope. Corrective action has been implemented to preclude the likelihood of similar events.
Patient Sequence No: 1, Text Type: N, H10


[18168626] The inner and outer packaging was adhered together upon opening. There was no adverse consequence for the pt or delay in surgery or anesthesia time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2219689-1997-00198
MDR Report Key86232
Report Source07
Date Received1997-04-16
Date of Report1997-04-15
Date of Event1997-03-12
Date Facility Aware1997-03-12
Report Date1997-04-15
Date Mfgr Received1997-03-12
Date Added to Maude1997-04-25
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 Location3
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameMED HOWMEDICA BONE PLUG 1PK
Generic NameIMPLANT
Product CodeMBS
Date Received1997-04-16
Model NumberNA
Catalog Number6215-5-011
Lot NumberUUMLA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key85425
ManufacturerHOWMEDICA, INC.
Manufacturer Address359 VETERANS BLVD. RUTHERFORD NJ 070702584 US
Baseline Brand NameARTISAN BONE PLUG
Baseline Generic NameBONE PLUG
Baseline Model NoNA
Baseline Catalog No6215-5-011
Baseline IDNA
Baseline Device FamilyBONE PLUG
Baseline Shelf Life ContainedN
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK951860
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-04-16

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