• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID WHITE 3/0 (2) 100M SUTURES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B.BRAUN SURGICAL SA SUPRAMID WHITE 3/0 (2) 100M SUTURES Back to Search Results
Model Number F1184040
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: evaluation on-going.

 
Event Description

Country of complaint: (b)(6). Suture has self retracted back into the cassette, cannot be used.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSUPRAMID WHITE 3/0 (2) 100M
Type of DeviceSUTURES
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, barcelona 08191
SP 08191
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key7025039
MDR Text Key92801632
Report Number3003639970-2017-00549
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberF1184040
Device Catalogue NumberF1184040
Device LOT Number616475
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date11/06/2017
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/13/2017 Patient Sequence Number: 1
-
-