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U.S. Department of Health and Human Services

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

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RAYNHAM CODMAN DISPOSABLE PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number XXX-CODMAN PERFORATOR
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem Brain Injury (2219)
Event Date 01/17/2022
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported the tip of a disposable perforator plunge into the patient's skull after the bone was completely through and the tip did not stop as it is designed to.It tore through the dura unintentionally.
 
Manufacturer Narrative
The perforator was not returned for evaluation after several attempts for product return and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
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Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key15473480
MDR Text Key300561414
Report Number3014334038-2022-00214
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 User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/01/2022
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 NumberXXX-CODMAN PERFORATOR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/07/2022
Initial Date FDA Received09/23/2022
Supplement Dates Manufacturer Received11/10/2022
Supplement Dates FDA Received12/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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