• 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 MANIPLER AZ - 35W SKINSTAPLER MECHANICAL 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 MANIPLER AZ - 35W SKINSTAPLER MECHANICAL SUTURES Back to Search Results
Model Number 783100
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

Manufacturing site evaluation: investigation on-going. Additional information/investigation results will be provided in a supplemental report.

 
Event Description

It was reported that there was an issue with the skin stapler. According to the client, infections occurred. The date and further details were not yet specified. Additional information was not provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMANIPLER AZ - 35W SKINSTAPLER
Type of DeviceMECHANICAL SUTURES
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, 08191
SP 08191
Manufacturer Contact
silvia salud orus
121 carretera de terrassa
rubi, 08191
SP   08191
MDR Report Key9126050
MDR Text Key163816411
Report Number3003639970-2019-00670
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number783100
Device Catalogue Number783100
Device LOT NumberU198013600
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/26/2019 Patient Sequence Number: 1
-
-