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: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS
  • 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
 

RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number 261221
Device Problem Failure to Auto Stop (2938)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that the perforator did not stop when surgeon arrived to the space between the cranial bone and dura-mater.There was no adverse event or delay in surgery.
 
Event Description
N/a.
 
Manufacturer Narrative
Udi (b)(4).The device was returned for evaluation and visually inspected utilizing unaided eye.No anomalies were observed other than a worn label.Test performed and the unit was found to performed as intended.Unit completed testing (5 holes) and was found to performed as intended.Complaint could not be verified as the unit was found to meet all acceptance criteria.A review of quality records was conducted and prior to distribution.This device met all manufacturing and quality testing/inspection specifications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key8460485
MDR Text Key145247903
Report Number1226348-2019-00023
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number261221
Device Lot NumberHU6935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2019
Initial Date Manufacturer Received 03/21/2019
Initial Date FDA Received03/28/2019
Supplement Dates Manufacturer Received06/12/2019
Supplement Dates FDA Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-