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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MANIPLER AZ - 35W SKINSTAPLER SKIN STAPLER

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B.BRAUN SURGICAL SA MANIPLER AZ - 35W SKINSTAPLER SKIN STAPLER Back to Search Results
Model Number 783100
Device Problem Device Operates Differently Than Expected (2913)
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 any other technological characteristics with a medical device registered within the u. S. (b)(4). Manufacturing site evaluation: on-going.

 
Event Description

Country of complaint: (b)(6). The customer is not satisfied with the results. The manipler pulls the wound ends too tight together. Also it seems that the clamps are too blunt. The skin is being pushed together before the camps is able to push through the skin.

 
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Brand NameMANIPLER AZ - 35W SKINSTAPLER
Type of DeviceSKIN STAPLER
Manufacturer (Section D)
B.BRAUN SURGICAL SA
121 carretera de terrassa
rubi, barcelona 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 Key5380966
MDR Text Key36469515
Report Number2916714-2016-00039
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/01/2020
Device MODEL Number783100
Device Catalogue Number783100
Device LOT NumberU15801070
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2016
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date01/18/2016
Event Location No Information
Date Manufacturer Received12/22/2015
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/20/2016 Patient Sequence Number: 1
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