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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. MONOMAX VIOLET 1 (4) 90CM HR48 (M); SYNTHETIC ABSORBABLE SUTURE
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B. BRAUN SURGICAL S.A. MONOMAX VIOLET 1 (4) 90CM HR48 (M); SYNTHETIC ABSORBABLE SUTURE Back to Search Results
Model Number B0041138
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 04/01/2014
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).The inner pouch sticks to the outer pouch.It is hard to get it out and often the scrub nurses are getting contaminated and have to change gloves as a result.
 
Manufacturer Narrative
Mfg site eval: eval is on-going.
 
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Brand Name
MONOMAX VIOLET 1 (4) 90CM HR48 (M)
Type of Device
SYNTHETIC ABSORBABLE 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
michelle link
615 lambert pointe dr.
hazelwood, MO 63042
3145515938
MDR Report Key3829802
MDR Text Key4502370
Report Number2916714-2014-00333
Device Sequence Number1
Product Code NWJ
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K100876
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 05/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2019
Device Model NumberB0041138
Device Catalogue NumberB0041138
Device Lot Number114053
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/11/2014
Initial Date FDA Received05/06/2014
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 Sequence Number1
Patient Outcome(s) Other;
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