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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/4 X 6 PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/4 X 6 PADDIE, COTTONOID Back to Search Results
Catalog Number 24-5431
Device Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Date 05/16/2017
Event Type  malfunction  
Manufacturer Narrative
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. 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. Device not available.
 
Manufacturer Narrative
Udi: (b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by the distributor, a 10 pack of patties contained only 9. Sample will be returned.
 
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Brand NameBULK SURG STRIP 1/4 X 6
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 Key6634730
MDR Text Key161460169
Report Number1226348-2017-10395
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 Received06/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5431
Device Lot NumberH48436
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 Received06/26/2017
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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