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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIL LIFE SCIENCES PVT. LTD. MOZECTM RX PTCA BALLOON DILATATION CATHETER; RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER

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MERIL LIFE SCIENCES PVT. LTD. MOZECTM RX PTCA BALLOON DILATATION CATHETER; RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER Back to Search Results
Model Number MOZ20015
Device Problems Off-Label Use (1494); Device Slipped (1584); Device Issue (2379); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Human Factors Issue (2948); Physical Property Issue (3008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2019
Event Type  malfunction  
Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information under good faith effort.But, neither the device specific lot number was provided nor was the concomitant product returned.Thus, a complaint investigation could not be performed.However, further investigation will be performed if the lot number or the associated device is received.Meril shall submit a supplement report accordingly.
 
Event Description
The tip of the balloon came off while trying to reload the balloon on the wire for a second inflation.
 
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Brand Name
MOZECTM RX PTCA BALLOON DILATATION CATHETER
Type of Device
RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
Manufacturer (Section D)
MERIL LIFE SCIENCES PVT. LTD.
bilakhia house, survey no. 135
muktanand marg
chala, vapi 39619 1
IN  396191
Manufacturer (Section G)
MERIL LIFE SCIENCES PVT. LTD.
bilakhia house, survey no. 135
muktanand marg
chala, vapi 39619 1
IN   396191
Manufacturer Contact
narendra patel
bilakhia house, survey no. 135
muktanand marg
chala, vapi 39619-1
IN   396191
MDR Report Key7432832
MDR Text Key105697574
Report Number3009613036-2018-00009
Device Sequence Number1
Product Code LOX
UDI-Device Identifier18904224907598
UDI-Public18904224907598
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Health Professional
Remedial Action Replace
Type of Report Initial
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMOZ20015
Device Catalogue NumberMOZ20015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/17/2018
Initial Date FDA Received04/16/2018
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 Sequence Number1
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