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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE PATTIE, COTTONOID Back to Search Results
Catalog Number 24-5411
Device Problem Material Frayed (1262)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
It is not clear at this point if the device and/or lot information is available. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If the device is returned the complaint will be investigated and a follow up report will be filed. If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
 
Manufacturer Narrative
Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the lot number was not provided so traveler documentation could not be reviewed. Visual inspection confirmed visual fraying on pattie edges. This product is documented in the ifu as low linting. While there is variation inherent in our manufacturing process of the cottonoid material, our objective is to produce product with the least possible amount of linting. Therefore lot to lot variation in the cottonoid process may result in lots that lint more or less than the norm. "linting" can also come from the quality of the edge cut from the slitting process, but the parts received did not show that issue. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
 
Manufacturer Narrative
Udi: (b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by medline, a customer received codman neuro sponges that were frayed around the edges. Event did not occur intraoperatively, cause any delays or adverse consequences. Another package was taken from the shelf to replace.
 
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Brand NameCODMAN SURGICAL PATTIE
Type of DevicePATTIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6866529
MDR Text Key247444702
Report Number1226348-2017-10679
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5411
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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