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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 Component Missing (2306)
Patient Problem No Information (3190)
Event Date 05/22/2017
Event Type  malfunction  
Manufacturer Narrative
Upon completion of the investigation, it was noted that the operators are required to 100 % inspect all the strips before they are packaged. The strip machine ran out of x-ray monofilament and operator missed the full inspection. A ilc was opened to make the operator aware of the complaint. A retraining was conducted to assist the operator in the future. 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, one surgical strip had the radiopaque line only half way down the cottonoid. Distributor will return for evaluation.
 
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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 Key6661611
MDR Text Key130225800
Report Number1226348-2017-10426
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 Received06/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5432
Device Lot NumberH33014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2017
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

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