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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. NOVOSYN VIOLET 2/0 (3) 4X45CM HR26TO (M); SYNTHETIC ABSORBABLE SUTURE
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B. BRAUN SURGICAL S.A. NOVOSYN VIOLET 2/0 (3) 4X45CM HR26TO (M); SYNTHETIC ABSORBABLE SUTURE Back to Search Results
Model Number C0088742
Device Problem Battery charger, defective (1054)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2014
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).Tip of the needle bends easily when grabbed with forcep during tissue penetration.
 
Manufacturer Narrative
Us reporting agent notified on: (b)(4) 2014.Evaluation on-going at manufacturing site.
 
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Brand Name
NOVOSYN VIOLET 2/0 (3) 4X45CM HR26TO (M)
Type of Device
SYNTHETIC ABSORBABLE SUTURE
Manufacturer (Section D)
B. BRAUN SURGICAL S.A.
rubi (barcelona) 0819 1
SP  08191
Manufacturer (Section G)
B. BRAUN SURGICAL S.A.
121 carretera de terrassa
rubi (barcelona) 0819 1
SP   08191
Manufacturer Contact
michelle link
615 lambert pointe dr.
hazelwood, MO 63042
3145515938
MDR Report Key3877222
MDR Text Key21733761
Report Number2916714-2014-00367
Device Sequence Number1
Product Code GAM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K122734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/01/2018
Device Model NumberC0088742
Device Catalogue NumberC0088742
Device Lot Number113301V004
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/09/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2013
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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