Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 PAT 1X3; 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 & SHURTLEFF, INC. BULK SURG PAT 1X3; PATTIE, COTTONOID Back to Search Results
Catalog Number 24-5412
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 08/24/2018
Event Type  malfunction  
Manufacturer Narrative
Udi - (b)(4).Attempts are being made to obtain additional information.A review of manufacturing information found no discrepancies when the device was released to stock.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the distributor, a 10 pack of surgical patties contained 9.The incident was noted prior to procedure and no delays were reported.
 
Manufacturer Narrative
It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BULK SURG PAT 1X3
Type of Device
PATTIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key7902877
MDR Text Key121567415
Report Number1226348-2018-10670
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 distributor
Type of Report Initial,Followup
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number24-5412
Device Lot NumberHN8651
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-