MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOSABLE PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number XXX-CODMAN PERFORATOR

Device Problem Failure to Auto Stop (2938)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

The customer reported that the perforator do not stop and there is damage on dura matter.

Manufacturer Narrative

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.

• 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 Key: 8843545
• MDR Text Key: 152755929
• Report Number: 1226348-2019-00305
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CODMAN PERFORATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 08/21/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1