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

MAUDE Adverse Event Report: CODMAN SURGICAL PATTIE PATTIE, 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 SURGICAL PATTIE PATTIE, COTTONOID Back to Search Results
Catalog Number 24-5411
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 07/24/2017
Event Type  malfunction  
Manufacturer Narrative
Device was returned for evaluation. Upon completion of the investigation a followup report will be filed.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the review of the device history records and product was done and no anomalies were found. This lot code appears to have met all testing requirement, there were no anomalies noted during manufacturing process. This product is documented in the ifu as low linting. While there is variation inherent in our manufacturing process of the cottonoid material, our objective is to produce product with the least possible amount of linting. Therefore, lot to lot variation in the cottonoid process may result in lots that lint more or less than the norm. "linting" can also come from the quality of the edge cut from the slitting process, but the parts received did not show that issue. 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, the strings were detaching from the surgical patties. There were no reports of delays or adverse consequences.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCODMAN SURGICAL PATTIE
Type of DevicePATTIE, COTTONOID
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6794133
MDR Text Key247117931
Report Number1226348-2017-10597
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,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5411
Device Lot NumberHA3814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
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

-
-