• 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 S.A. DAFILON BLUE 5/0 (1) 45CM DSMP16 (M) NYLON SUTURE

  • 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 S.A. DAFILON BLUE 5/0 (1) 45CM DSMP16 (M) NYLON SUTURE Back to Search Results
Model Number C0936154
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Wound Dehiscence (1154)
Event Type  Malfunction  
Event Description

Country of complaint: (b)(4). Needle bent, blunt and knotting is difficult. Dehiscence and extrusion points.

 
Manufacturer Narrative

Waiting for product return. Us reporting agent notified on: (b)(4) 2015. Evaluation is ongoing.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAFILON BLUE 5/0 (1) 45CM DSMP16 (M)
Type of DeviceNYLON SUTURE
Manufacturer (Section D)
B. BRAUN SURGICAL S.A.
rubi (barcelona) 0819 1
ES 08191
Manufacturer (Section G)
B. BRAUN SURGICAL SA
121 carretera de terrassa
rubi (barcelona) 0819 1
ES 08191
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key4436159
MDR Text Key5316660
Report Number2916714-2015-00008
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK990090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date05/01/2019
Device MODEL NumberC0936154
Device Catalogue NumberC0936154
Device LOT Number614195
Date Manufacturer Received12/02/2014
Was Device Evaluated By Manufacturer? No
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: 01/06/2015 Patient Sequence Number: 1
-
-