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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH HOLDSLEEVE W/WINGSCR L85 I-Ø 6 F/MED-DIS APPARATUS, TRACTION, NON-POWERED

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SYNTHES GMBH HOLDSLEEVE W/WINGSCR L85 I-Ø 6 F/MED-DIS APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 395.46
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameHOLDSLEEVE W/WINGSCR L85 I-Ø 6 F/MED-DIS
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14788977
Report Number8030965-2022-04276
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number395.46
Device Lot NumberL498349
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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