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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 09/25/2017
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. 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. No further action is required. 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.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by medline, a customer received a pack of surgical strips that had an incorrect amount. Instead of 10 the pack contained 9 strips. Event was noticed during set up. Replacement product was used to complete procedure. No report of delay or patient harm.
 
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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 Key6987131
MDR Text Key247570807
Report Number1226348-2017-10793
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5431
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 Received11/06/2017
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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