• 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. BULK SURG STRIP 1/4 X 6 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. 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 07/13/2017
Event Type  malfunction  
Manufacturer Narrative
Manufacturing documentation was reviewed. Nothing was found to be out of the ordinary with this work order. Per the requirements of the specification the operator is required to count the amount of surgical strips and weigh the package with the strips to verify the count prior to sealing them in the package. Although we were unable to confirm the reported issue, retraining was performed with all the operators that had worked on this product and lot number. Based on the information provided, the cause(s) of the difficulty reported by the customer could not be determined. Complaint will be closed as 'no complaint sample returned to codman for evaluation'. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints.
 
Manufacturer Narrative
(b)(4). It has been communicated that the device is not available for evaluation. Without the device it is not possible for codman to conduct a proper investigation. Since a lot number has been provided a review of the manufacturing records will be reviewed. We anticipate that the evaluation will reveal that the device conformed to specifications prior to release. If anything otherwise is found then a follow up report will be filed. If at some point the device 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)(6), a neuro strip 10 pack contained 8 strips.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6786499
MDR Text Key247572635
Report Number1226348-2017-10562
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 company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5431
Device Lot NumberH52406
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 Received11/07/2017
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

-
-