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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CLAMP,CIRCUMCISION,GOMCO,11MM,1.1CM
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MEDLINE INDUSTRIES LP; CLAMP,CIRCUMCISION,GOMCO,11MM,1.1CM Back to Search Results
Catalog Number MDS9382111
Device Problem Pressure Problem (3012)
Patient Problem Genital Bleeding (4507)
Event Date 11/30/2023
Event Type  Injury  
Manufacturer Narrative
It was reported by the customer contact that on (b)(6) 2023, "instrument did not tighten properly and impacted the procedure".It was reported that due to this, "the infant had additional post procedure bleeding.Silver nitrate had to be applied and discharge was delayed several hours so the patient could be monitored".A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Event Description
Post procedure bleeding.
 
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Type of Device
CLAMP,CIRCUMCISION,GOMCO,11MM,1.1CM
Manufacturer (Section D)
MEDLINE INDUSTRIES LP
three lakes drive
northfield IL 60093
Manufacturer Contact
kelly zampella
three lakes drive
northfield, IL 60093
MDR Report Key18477364
MDR Text Key332456373
Report Number1417592-2024-00018
Device Sequence Number1
Product Code HFX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberMDS9382111
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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