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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 4/0 (1.5) 45CM DS19 OTHER SUTURE

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B.BRAUN SURGICAL SA SUPRAMID BLACK 4/0 (1.5) 45CM DS19 OTHER SUTURE Back to Search Results
Model Number C0712205
Device Problems Material Frayed (1262); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S. K99090. If additional information becomes available a follow up report will be submitted.

 
Event Description

It was reported the coating is peeling off. The reporter indicated that the supramid coating was peeling off the thread. No reported patient injury. Additional information has not been provided.

 
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Brand NameSUPRAMID BLACK 4/0 (1.5) 45CM DS19
Type of DeviceOTHER SUTURE
Manufacturer (Section D)
B.BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP 08191
Manufacturer (Section G)
B/ BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP 08191
Manufacturer Contact
silvia orus
carretera de terrassa, 121
rubi, barcelona 08191
SP   08191
MDR Report Key9008574
MDR Text Key159357089
Report Number3003639970-2019-00636
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberSEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC0712205
Device Catalogue NumberC0712205
Device LOT Number618275
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 Received11/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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