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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN* SURG STRIP 1X6 PADDIE, COTTONOID

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CODMAN* SURG STRIP 1X6 PADDIE, COTTONOID Back to Search Results
Catalog Number 80-1453
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative
Product was not returned therefore complaint could not be verified. In the absence of the complaint sample, a complaints records review was conducted. The dhr/manufacturing lot traveler was pulled and reviewed. All information on the traveler indicates that the product was produced within specifications. There were no engineering change orders or anything unusual relative to the manufacturing documentation of this lot. The root cause could not be determined. No corrective action will be taken at this time. We will continue to monitor future complaints on this lot number for similar issues. This complaint is considered to be closed, should the product be made available for evaluation at a later date we will re-open this complaint and evaluate the product.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by the distributor, a pack of codman 1x 6 surgical strips contained a dead bug. A delay of 45 minutes was reported. Besides the delay, the patient was not affected.
 
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Type of DevicePADDIE, COTTONOID
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6988246
MDR Text Key110954075
Report Number1226348-2017-10799
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number80-1453
Device Lot NumberH38727
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2017
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 Treatment Data
Date Received: 10/30/2017 Patient Sequence Number: 1
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