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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TOP NEEDLE; SURGICAL ADJUNCTS

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ABBOTT MEDICAL OPTICS TOP NEEDLE; SURGICAL ADJUNCTS Back to Search Results
Model Number TOP27G22
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Date of event: unknown, not provided.If implanted, give date: not applicable.If explanted, give date: not applicable.(b)(6).Device manufacture date: unknown.All pertinent information available to abbott medical optics has been submitted.
 
Event Description
It was reported that a customer ordered top needle angle 27g22 and the customer received top27g22, lot-5k08m.However, the label on the tyvek pack of the inside product was top needle straight 27g26(top27g26), lot-5l01m.No patient injury reported.No patient contact reported.No additional information was provided.
 
Manufacturer Narrative
Corrected data: upon further review of this file it was determined that the initial mdr was filed in error.The reported device is not same or similar to a product distributed/ sold in the united states.Device evaluation: the returned product was received at the manufacturer.There were no manufacturing errors identified on the returned product.Therefore, no product deficiency was identified.This may have been a user error issue.Additionally, there were no discrepancies or defects found during the manufacturing record review (mrr).The documentation shows that the production order was manufactured according to specifications.Based on the investigation results there is no indication of product quality deficiency.All pertinent information available to the manufacturer has been submitted.
 
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Brand Name
TOP NEEDLE
Type of Device
SURGICAL ADJUNCTS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
Manufacturer (Section G)
ABBOTT MEDICAL OPTICS INC.
van swietenlaan 5
groningen 9728 NX
NL   9728 NX
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana, CA 92705
7142478243
MDR Report Key5810047
MDR Text Key50075811
Report Number3004750704-2016-00013
Device Sequence Number1
Product Code LZP
Combination Product (y/n)N
PMA/PMN Number
P810031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/07/2016
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 Physician
Device Expiration Date08/31/2020
Device Model NumberTOP27G22
Device Lot Number5K08M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/20/2016
Initial Date FDA Received07/20/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/07/2016
Was Device Evaluated by Manufacturer? Yes
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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