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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VERISET; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
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COVIDIEN LP LLC NORTH HAVEN VERISET; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED Back to Search Results
Model Number HP0510E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Abnormal Vaginal Discharge (2123); Vaginal Mucosa Damage (2124)
Date of Event 11/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, post-operatively on a total abdominal hysterectomy procedure, the patient developed a vaginal discharge and passage of mucous substance in the vagina.They examined the patient and removed what appeared to the device extruding through vaginal vault.The device was the only foreign body left in the area.
 
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Brand Name
VERISET
Common Device Name
AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key8447790
Report Number1219930-2019-01755
Device Sequence Number14217261
Product Code LMG
UDI-Device Identifier20884521082554
UDI-Public20884521082554
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberHP0510E
Device Catalogue NumberHP0510E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2019
Initial Report FDA Received Date03/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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