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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM UNKNOWN SURGICAL PATTIE
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RAYNHAM UNKNOWN SURGICAL PATTIE Back to Search Results
Catalog Number XXX-SURGICAL PATTIE
Device Problem Contamination (1120)
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 contaminated (stain) surgical pattie.No additional information available.
 
Manufacturer Narrative
The neuro pattie was not returned for evaluation 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.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
UNKNOWN SURGICAL PATTIE
Type of Device
SURGICAL PATTIE
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA
MDR Report Key12374393
MDR Text Key268370001
Report Number3014334038-2021-00181
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberXXX-SURGICAL PATTIE
Was Device Available for Evaluation? No
Date Manufacturer Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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