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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:
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Device Problem Material Fragmentation (1261)
Patient Problems Unspecified Infection (1930); Pain (1994); Skin Irritation (2076); Tissue Damage (2104); Impaired Healing (2378); Device Embedded In Tissue or Plaque (3165)
Event Date 10/06/2017
Event Type  Injury  
Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed to be a serious injury and a reportable malfunction.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional patient/event details have been requested but none have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
 
Event Description
It was reported that an "unomedical wound drain, exact model, batch etc.Unknown due to time passed between incident ((b)(6) 2017) and reporting by patient ((b)(6) 2018), the drain would have been disposed of shortly after removal on (b)(6) 2017.Current evidence suggest that part of the wound drain was retained after on-ward removal by nurse, the exact nature of the defect is not known, because the drain was disposed of after removal and the retained portion is still within the patient.¿ details of injury (to patient, carer or healthcare professional): patient had left total knee replacement in (b)(6) 2016.Patient re-admitted on (b)(6) 2017 (left knee: release of adhesion, exchange of poly, patellar resurfacing).Patient discharged on (b)(6) 2017.Complaint received on (b)(6) 2018 states that on (b)(6) drain was removed from left knee by nurse on ward, removal of drain was painful and wound took prolonged period to heal and required antibiotics prescribed by general practitioner (gp).Patient continued to experience problems with left knee." additionally, the acting governance business partner, surgery and critical care reported "based on the currently available evidence it seems the drain broke during removal, at present we do not know if this was due to a manufacturing defect, damage during the surgical procedure, damage during the removal procedure, or some combination of these.There were no significant issues with the surgical procedure wound.Based on information provided by the patient, the patient was diagnosed as suffering from an infection by their gp and was prescribed anti-biotics, we are not aware that any lab testing was undertaken.This information has not been verified by us.The patient has reported delayed healing, reddening and irritation of the wound drain site, this was also documented by out physiotherapy staff.According to ultrasound scan the fragment is approximately 20mm in length." the patient's outcome was reported as "the outcome from the surgical procedure is as expected, with no significant issues reported apart from the retained drain fragment." it was reported that the patient is scheduled to have drain fragment removal surgery on (b)(6) 2018.A photograph was requested but, has not been received.No further information was provided.
 
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MDR Report Key7527165
MDR Text Key108725993
Report Number3007966929-2018-00010
Device Sequence Number1
Product Code GCY
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other
Type of Report Initial
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/25/2018
Initial Date FDA Received05/18/2018
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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