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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES UNKNOWN; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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APPLIED MEDICAL RESOURCES UNKNOWN; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Type  malfunction  
Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to manufacturer.A follow-up report will be provided upon completion of the investigation.
 
Event Description
Name of procedure being performed: lap.Chole.Detailed description of event: limited information is available at the time of reporting.Rep.Stated that the patient originally had surgery in (b)(6) 2019 and came back to the hospital last week since their umbilical incision site was not healing.When the surgeon re-operated on the patient, he noticed that a piece of plastic was left inside the patient.The color of the plastic piece is unknown and the model number is also unknown.Rep mentioned that this doctor doesn't use any applied medical trocars and only uses inzii's.Patient status: unknown at this time.Type of intervention: removed a piece of plastic left in the patient from a previous surgery in (b)(6) 2019.
 
Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to confirm that a product malfunction occurred.
 
Event Description
Name of procedure being performed: lap.Chole.Detailed description of event: limited information is available at the time of reporting.Rep.Stated that the patient originally had surgery in (b)(6) 2019 and came back to the hospital last week since their umbilical incision site was not healing.When the surgeon re-operated on the patient, he noticed that a piece of plastic was left inside the patient.The color of the plastic piece is unknown and the model number is also unknown.Rep mentioned that this doctor doesn't use any applied medical trocars and only uses inzii's.Additional information was received from applied medical account manager, via e-mail on january 28th, 2020: "i spoke with [name] yesterday along with two other applied managers and he said he forwarded the email form you to their risk management department.I am not sure if anyone will respond or not but he said he will not be answering any more questions.We requested a piece that was sent to pathology and the pathology notes but not sure they even have that information for us.I just wanted to let you know what was going on.Thanks so much [name]".Patient status: unknown at this time.Type of intervention: removed a piece of plastic left in the patient from a previous surgery in (b)(6) 2019.
 
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Brand Name
UNKNOWN
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
MDR Report Key9645056
MDR Text Key177153832
Report Number2027111-2020-00341
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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