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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURG PAT XRAY 1/2X2 (200) PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. SURG PAT XRAY 1/2X2 (200) PADDIE, COTTONOID Back to Search Results
Catalog Number 80-1406
Device Problem Incorrect Device Or Component Shipped (2962)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by the ous affiliate, a 10-pack of patties contained 11. There were no reports of delay or patient harm.
 
Manufacturer Narrative
(b)(4). It was previously reported that the device would be returned for evaluation. Multiple attempts to obtain the sample were not successful. Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed. A review of manufacturing records found no discrepancies when the device was released to stock. The cause(s) of the difficulty reported by the customer could not be determined. 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. At present, we consider this complaint to be closed.
 
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Brand NameSURG PAT XRAY 1/2X2 (200)
Type of DevicePADDIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key7299712
MDR Text Key101256016
Report Number1226348-2018-10192
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1406
Device Lot NumberHD1128
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

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