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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA C-VIEW 20X30CM

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ASPEN SURGICAL PRODUCTS, CALEDONIA C-VIEW 20X30CM Back to Search Results
Model Number 2258
Device Problem Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Date 08/01/2017
Event Type  malfunction  
Manufacturer Narrative
Device not returned, pictures provided.
 
Event Description
Customer reported they found open pouches of the c-view film 20x30cm, lot: 125803; exp-date: 2020-02.The picture depicts two films in one pouch where sealing was performed on the film itself, causing an open pouch.
 
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Brand Name
C-VIEW 20X30CM
Type of Device
C-VIEW
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
megan morrissey
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key6832171
MDR Text Key84120561
Report Number1836161-2017-00081
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2020
Device Model Number2258
Device Lot Number125803
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/01/2017
Initial Date FDA Received08/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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