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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN* SURG STRIP 1/2X6 PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. CODMAN* SURG STRIP 1/2X6 PADDIE, COTTONOID Back to Search Results
Catalog Number 80-1451
Device Problem Incorrect Device Or Component Shipped (2962)
Patient Problem No Information (3190)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the lot history records did not show any anomalies during the manufacturing process. Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.
 
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. We will continue to monitor for this or similar complaints for this product code. 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
A partial device was returned for evaluation. Without the complete device, we were unable to confirm the issue reported by the customer or determine potential root cause. A review of manufacturing records found no discrepancies when the device was released to stock. If additional relevant information becomes available, the complaint will be reopened and a follow-up report will be submitted. Trends will be monitored for this and similar complaints. At present, we consider this report to be closed.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed. A review of the lot history records did not show any anomalies during the manufacturing process.
 
Event Description
As reported by the rep, a 10 pack of surgical patties contained 11. There were no reports of delay or patient harm. More information is being requested.
 
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Type of DevicePADDIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key7169430
MDR Text Key273204647
Report Number1226348-2018-10030
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1451
Device Lot NumberHD6262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Is This a Reprocessed and Reused Single-Use Device? No

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