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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE PADDIE, COTTONOID Back to Search Results
Catalog Number 80-1403
Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4) upon completion of the investigation a follow up report will be filed.
 
Event Description
Yesterday in the neuro room they lost a cottonoid, and eventually found it, but in the process of looking for it, they shot a "test" xray to see if the cottoinoid would even show up on xray. It did not. They were using a 1x1 cottonoid for the test, and clinician said you could barely see the line. They showed me again just now in the case we're in, clinician placed a 1x1 cottonoid in the wound and you can't even see it under x-ray. This is a huge concern! we used to be able to see the lines on them much better.
 
Manufacturer Narrative
Correction: device available for evaluation?, device evaluated by mfr? additional info: device available for evaluation?, date received by mfr, type of report, if follow-up, what type?, device evaluated by mfr and evaluation codes. The customer was contacted regarding product returned; however, the product was not returned for evaluation. As such it is not possible to evaluate the product and determine the root cause of this complaint. Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed. We will continue to monitor for this or similar complaints for this product code. At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.
 
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Brand NameCODMAN SURGICAL PATTIE
Type of DevicePADDIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key5538920
MDR Text Key41579360
Report Number1226348-2016-10250
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number80-1403
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 Received04/18/2016
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: 03/31/2016 Patient Sequence Number: 1
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