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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG PAT 1/2 X 1/2 PADDIE, COTTONOID
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CODMAN & SHURTLEFF, INC. BULK SURG PAT 1/2 X 1/2 PADDIE, COTTONOID Back to Search Results
Catalog Number 24-5404
Device Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Date 06/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It has been communicated that the device and/or lot information is not available for evaluation. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed. Device not available.
 
Event Description
As reported by (b)(4), a customer received a codman surgical 10-pack containing 9 patties. Event did not occur intraoperatively; another package was pulled from shelf. There were no reports of delays or adverse consequences.
 
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Brand NameBULK SURG PAT 1/2 X 1/2
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 Key6866416
MDR Text Key86589554
Report Number1226348-2017-10678
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
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 Number24-5404
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 Received08/24/2017
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

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