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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ CODMAN AND SHURTLEFF CODMAN DISPOSABLE PERFORATOR; CRANIAL PERFORATOR

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JOHNSON AND JOHNSON/ CODMAN AND SHURTLEFF CODMAN DISPOSABLE PERFORATOR; CRANIAL PERFORATOR Back to Search Results
Model Number 26-1221
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Eye Injury (1845); Hematoma (1884); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pain (1994); Blurred Vision (2137)
Event Date 12/13/2016
Event Type  malfunction  
Event Description
Codman disposable perforator 14mm (lotjj011s) malfunctioned while in use by physician attending.Item removed from sterile field and was saved to be given to codman rep.Codman rep notified.A (b)(6), presented to ed with 2 days ha, and pain behind right eye, blurred vision, b/p elevated, head ct shown acute parenchymal hemorrhage, taken to operating room for craniotomy to evacuate hematoma.
 
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Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
CRANIAL PERFORATOR
Manufacturer (Section D)
JOHNSON AND JOHNSON/ CODMAN AND SHURTLEFF
new brunswick NJ 08933
MDR Report Key6193330
MDR Text Key63133709
Report NumberMW5066823
Device Sequence Number1
Product Code KAT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2021
Device Model Number26-1221
Device Lot NumberJJO13S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/19/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age60 YR
Patient Weight99
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