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

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.

• Brand Name: SUTURE
• Type of Device: LAPAROSCOPE, 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 Key: 7627403
• MDR Text Key: 111973212
• Report Number: 1219930-2018-03322
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• 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 Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN - SUTUR
• Device Catalogue Number: UNKNOWN - SUTUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR