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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT PERI TRAY GYN PACK-LF; GYNECOLOGICAL LAPAROSCOPIC KIT

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MEDLINE INDUSTRIES, LP - SPT PERI TRAY GYN PACK-LF; GYNECOLOGICAL LAPAROSCOPIC KIT Back to Search Results
Lot Number (10) 22BBT772
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2022
Event Type  malfunction  
Event Description
Black spec found in prep tray after chg had been poured - not sure if it was from the prep kit or the chg bottle.Both items quarantined and removed from operating room - did not touch patient.
 
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Brand Name
PERI TRAY GYN PACK-LF
Type of Device
GYNECOLOGICAL LAPAROSCOPIC KIT
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP - SPT
MDR Report Key15130125
MDR Text Key296996384
Report NumberMW5111175
Device Sequence Number1
Product Code OHD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/14/2022
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 Lot Number(10) 22BBT772
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/28/2022
Patient Sequence Number1
Treatment
CHLORHEXIDINE GLUCONATE
Patient SexMale
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