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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC SPLIT STITCH; POLYBLEND BRAIDED STERILE NONABSORBABLE SUTURE
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RIVERPOINT MEDICAL LLC SPLIT STITCH; POLYBLEND BRAIDED STERILE NONABSORBABLE SUTURE Back to Search Results
Model Number VAL0220SS
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation.A review of device history record was performed and no issues were noted during manufacturing and all product met requirements prior to release.The report could not be substantiated and a cause for the event could not be established.
 
Event Description
According to the reporter, "suture shredded during the tendon transfer.".
 
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Brand Name
SPLIT STITCH
Type of Device
POLYBLEND BRAIDED STERILE NONABSORBABLE SUTURE
Manufacturer (Section D)
RIVERPOINT MEDICAL LLC
825 ne 25th ave
portland OR 97232
Manufacturer Contact
edwin anderson
825 ne 25th ave
portland, OR 97232
5038178001
MDR Report Key14246703
MDR Text Key290542480
Report Number3006981798-2022-00010
Device Sequence Number1
Product Code GAT
UDI-Device Identifier00818614020105
UDI-Public00818614020105
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVAL0220SS
Device Lot Number20111718
Was Device Available for Evaluation? No
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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