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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FH INDUSTRIE LIST
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FH INDUSTRIE LIST Back to Search Results
Catalog Number COMPLETE LIST IN ADD
Device Problems Calibration Error (1078); Imprecision (1307); Calibration Problem (2890)
Patient Problem No Code Available (3191)
Event Date 04/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Sealing defect is discovered: there is an error in the calibration performed by external service company.The blister / sealing formatting has been carried out at a value less than the minimum temperature validated.
 
Manufacturer Narrative
Product recall // incident report (b)(4) : 21 implants.Quantity: 0000000242451 vis secable autocompressive l26 f02301 1 (b)(6); 0000000231392 tete inox cone 12-14 28cm (0) f02708 1 (b)(6); 0000000231392 tete inox cone 12-14 28cm (0) f02708 1 (b)(6); 0000000231392 tete inox cone 12-14 28cm (0) f02708 1 (b)(6); 0000000231392 tete inox cone 12-14 28cm (0) f02708 1 (b)(6); 0000000257691 composant fem.Ps a/c t.2 ghe fhk f03587 1 (b)(6); 0000000257691 composant fem.Ps a/c t.2 ghe fhk f03587 1 (b)(6); 0000000257691 composant fem.Ps a/c t.2 ghe fhk f03587 1 (b)(6); 0000000257691 composant fem.Ps a/c t.2 ghe fhk f03587 1 (b)(6); 0000000257691 composant fem.Ps a/c t.2 ghe fhk f03587 3 (b)(6); 0000000257663 embase tibiale pf a/c t.5 fhk f03661 1 (b)(6); 0000000257663 embase tibiale pf a/c t.5 fhk f03661 1 (b)(6); 0000000257663 embase tibiale pf a/c t.5 fhk f03661 2 (b)(6); 0000000256693 cupule double mobilite hng t 56 rg01127 1 (b)(6); 0000000260132 *tete inox 12/14 athena ii 28 ss jupe -4 rg01203 1 (b)(6); 0000000260133 *tete inox 12/14 athena ii 28 ss jupe 0 rg01204 1 (b)(6); 0000000260134 *tete inox 12/14 athena ii 28 ss jupe +4 rg01205 1 (b)(6); 0000000254527 tete alumine 12/14 d.36 cl +3,5 rg01225 1 (b)(6).
 
Event Description
Sealing defect is discovered: there is an error in the calibration performed by external service company.The blister / sealing formatting has been carried out at a value less than the minimum temperature validated.
 
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Brand Name
LIST
Type of Device
LIST
Manufacturer (Section D)
FH INDUSTRIE
6 rue nobel
quimper, france 29000
FR  29000
Manufacturer (Section G)
FH INDUSTRIE
6 rue nobel
france, quimper 29000
FR   29000
Manufacturer Contact
renaud ruillier
3 rue de la fôret
heimsbrunn, france 68990
MDR Report Key5675260
MDR Text Key47119967
Report Number3003898228-2016-00005
Device Sequence Number1
Product Code MOO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 10/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCOMPLETE LIST IN ADD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received04/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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