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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE OYC

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ANIMAS CORPORATION ANIMAS VIBE OYC Back to Search Results
Device Problem Break (1069)
Patient Problems Swelling (2091); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to animas for evaluation. If the device is returned, an evaluation shall be completed and a supplemental report will be filed.
 
Event Description
On (b)(6) 2016, the reporter contacted animas and alleged that the patient had required surgery to remove broken sensor wires. The patient had started a new cgm session 1 month ago and used the sensor for 7 days before removing it from the skin. Approximately 3 weeks after the end of the session, patient's arm was swollen and had red marks. After examination, it was discovered that the little wires had broken off the sensor and the patient needed surgery to retrieve them. This complaint is being reported as the patient required surgical intervention to remove the sensor wires.
 
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Brand NameANIMAS VIBE
Type of DeviceOYC
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
4843561808
MDR Report Key5754913
MDR Text Key48318553
Report Number2531779-2016-13673
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 06/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/28/2016 Patient Sequence Number: 1
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