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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM SURG PATXRAY 3/4X3/4-200 SURGICAL PATTIES

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RAYNHAM SURG PATXRAY 3/4X3/4-200 SURGICAL PATTIES Back to Search Results
Catalog Number 801401
Device Problems Material Frayed (1262); Use of Device Problem (1670)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 04/11/2019
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that the doctor was using the pattie in a neuro/spine case to suction up blood. The pattie disintegrated while the doctor was pulling it out of the patient. The doctor had to go back in to collect all the small pieces.
 
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Brand NameSURG PATXRAY 3/4X3/4-200
Type of DeviceSURGICAL PATTIES
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA 02767
Manufacturer Contact
kimberly shelly
325 paramount drive
raynham, MA 02767
MDR Report Key8541010
MDR Text Key142795842
Report Number1226348-2019-00101
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number801401
Device Lot NumberJ0032U
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/30/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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