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 Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.
 
Event Description
The customer also reports that in the past, too, other perforators (which are not broken) have come too deep.There is no further information regarding these incidents.
 
Manufacturer Narrative
Udi (b)(4).The complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.This complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.
 
Event Description
N/a.
 
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 Key8951167
MDR Text Key156263928
Report Number1226348-2019-00388
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 company representative,foreig
Type of Report Initial,Followup
Report Date 07/29/2019
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/09/2019
Initial Date FDA Received08/30/2019
Supplement Dates Manufacturer Received10/29/2019
Supplement Dates FDA Received10/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-