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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/2 X 6 COTTONOID, PADDIE

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CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/2 X 6 COTTONOID, PADDIE Back to Search Results
Catalog Number 24-5432
Device Problem Material Frayed (1262)
Patient Problem No Information (3190)
Event Date 07/25/2017
Event Type  malfunction  
Manufacturer Narrative
It appears that this product was lost in shipping, not returned to the codman complaints department. Therefore, this complaint will be closed, should the product be found/returned to the complaints department the complaint will be re-opened and an investigation will be performed. At the present time this complaint is now closed.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by the distributor, surgical strips were linting.
 
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Brand NameBULK SURG STRIP 1/2 X 6
Type of DeviceCOTTONOID, PADDIE
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 Key6904225
MDR Text Key247447732
Report Number1226348-2017-10715
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 health professional
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5432
Device Lot NumberH43058
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 Received10/17/2017
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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