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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTRACT MANUFACTURER: TONTARRA MEDIZINTECHNICK UTERINE CLAMP ANG 300MM

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CONTRACT MANUFACTURER: TONTARRA MEDIZINTECHNICK UTERINE CLAMP ANG 300MM Back to Search Results
Model Number MB184R
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing site evaluation: on-going.

 
Event Description

It has been reported that the jaw of a uterine clamp broke. It has been reported that there was unknown surgical delay and unknown intervention.

 
Manufacturer Narrative

Investigation of the returned device indicated breakage at the area of the box hole; where the device is at its thinnest. All specifications (material and measurements) were valid at the time of production, no additional complaints have been received related to this item number. No material or manufacturing defects found. The breakage of the device is likely related to overloading or incorrect handling during use/processing.

 
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Brand NameUTERINE CLAMP ANG 300MM
Type of DeviceCLAMP
Manufacturer (Section D)
CONTRACT MANUFACTURER: TONTARRA MEDIZINTECHNICK
15 daimlerstr.
wurmlingen 78573
GM 78573
Manufacturer (Section G)
CONTRACT MANUFACTURER: TONTARRA MEDIZINTECHNICK
15 daimlerstr.
wurmlingen 78573
GM 78573
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key5828140
MDR Text Key51356814
Report Number2916714-2016-00641
Device Sequence Number1
Product Code HGC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMB184R
Device Catalogue NumberMB184R
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/28/2016
Event Location No Information
Date Manufacturer Received06/28/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/27/2016 Patient Sequence Number: 1
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