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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOSABLE PERFORATOR; DISPOSABLE PERFORATORS
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INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOSABLE PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number XXX-CODMAN PERFORATOR
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 a perforator failed to disengage.No additional information was provided.
 
Event Description
N/a.
 
Manufacturer Narrative
The perforator was not returned for evaluation and lot number information has not 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.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)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA
MDR Report Key12312210
MDR Text Key266179437
Report Number3014334038-2021-00164
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
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
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? No
Date Manufacturer Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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