• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURG STRIP 1/4X6 PADDIE, COTTONOID

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CODMAN & SHURTLEFF, INC. CODMAN SURG STRIP 1/4X6 PADDIE, COTTONOID Back to Search Results
Catalog Number 80-1450
Device Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Date 10/20/2017
Event Type  malfunction  
Manufacturer Narrative
Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation it was noted that the sample was received and reviewed. Miscount of 9 strips was confirmed. Dhr reviewed and tcr opened. The manufacturing documentation was pulled and reviewed. Nothing was found to be out of the ordinary with this work order. Root cause of "miscount" is likely due to operator error, this however could not be determined. Per the requirements of the specification the operator is required to inspect the front and back of each strip and count the stack. The operator than weighs the stack to make sure there are 10 strips prior to bagging the stack. A tr was opened to retrain all the operators that had worked on this product and lot #. It was determined that the operator must have miscounted the strips and due to the weight variation of a missing strip being so small the count scale must have accidentally counted the appropriate amount. 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
(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 codman surgical strips contained 9. There were no reports of delay or patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCODMAN SURG STRIP 1/4X6
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 Key7026308
MDR Text Key247651391
Report Number1226348-2017-10827
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1450
Device Lot NumberHA8252
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2017
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

-
-