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 DISPOSABLE 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 DISPOSABLE PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number XXX-CODMAN PERFORATOR
Device Problem Use of Device Problem (1670)
Patient Problem No Information (3190)
Event Date 03/26/2019
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 while drilling onto patient skull, the silver tip of the perforator stopped spinning while the plastic blue middle piece continued to spin.
 
Manufacturer Narrative
The device was returned for evaluation.The perforator was visually inspected utilizing an unaided eye.No anomalies were observed other than that the product label was worn.A series of holes were drilled per the test method without issue.The root cause for the complaint failure cannot be confirmed.Complaint was not related to the working functionality of the product.Unit was found to meet all applicable acceptance criteria.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key8505352
MDR Text Key145281759
Report Number1226348-2019-00071
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberXXX-CODMAN PERFORATOR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2019
Date Manufacturer Received06/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-