MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON POLYSORB 1 36 VIOLET BGS-24; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number CL951

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 02/14/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the patient underwent an elective caesarean section on (b)(6) 2013.She was discharged on (b)(6) 2013 and returned home with the plan for stitches to be removed on day 5.However on her return home, whilst coughing, her abdomen burst open and blood and loops of her small bowel protruded out of the wound.The paramedics were called and she was taken to hospital where she underwent a 2 1/2 hour operation to close the wound.Following the operation the plan was for staples for 10 days and 7 days antibiotics.The patient stayed in hospital for four days and was discharged on (b)(6) 2013.She has also suffered from psychological trauma.

• Brand Name: POLYSORB 1 36 VIOLET BGS-24
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: matthew amaral ; 60 middletown ave; north haven, CT 06473 ; 2034926373
• MDR Report Key: 5865727
• MDR Text Key: 51766889
• Report Number: 1219930-2016-00832
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K963253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL951
• Device Catalogue Number: CL951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention