• 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 1/2 X 1/2 PADDIE, 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 1/2 X 1/2 PADDIE, COTTONOID Back to Search Results
Catalog Number 24-5404
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). It has been reported that the device will not be returned for evaluation. However, a lot number has been provided. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the affiliate there was a miscount/component qty shortage of bulk surg pat 1/2 x 1/2 that was discovered prior to the procedure. There was no report of surgical delays or patient harm. The sample is not available.
 
Manufacturer Narrative
Udi: (b)(4). Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed. A review of the device history record found no discrepancies when the device was released to stock. The cause(s) of the difficulty reported by the customer could not be determined. 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 NameBULK SURG PAT 1/2 X 1/2
Type of DevicePADDIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key7923361
MDR Text Key122216883
Report Number1226348-2018-10686
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 09/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5404
Device Lot NumberHT0097
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-