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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SUTURE LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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COVIDIEN LP LLC NORTH HAVEN SUTURE LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number UNKNOWN - SUTUR
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Blood Loss (2597)
Event Date 09/11/2017
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, one week post vaginal hysterectomy and anterior and posterior vaginal wall repair of utero prolapse, the vaginal bleeding stopped. However, three months post procedure the patient had a gynecological examination due to vaginal bleeding, the vagina was unobstructed, but the suture line at the vaginal stump and needle eye had a little bleeding. This event was caused by poor absorption of the absorbable suture. They removed the suture and gave the patient anti-infection treatment.

 
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Brand NameSUTURE
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer (Section G)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key7627403
MDR Text Key111973212
Report Number1219930-2018-03322
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 06/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN - SUTUR
Device Catalogue NumberUNKNOWN - SUTUR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/21/2018 Patient Sequence Number: 1
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