MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON BIOSYN¿ MONOFILAMENT ABSORBABLE SUTURE 4-0 1.5 METRIC 18"; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number SM5627

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Abscess (1690); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested however only limited details were received and all available information at the time of this report, has been included.Should additional information be provided, the file will be updated.It has been reported that no product will be returned for evaluation.Only the gender of the patient (female) could be provided.

Event Description

According to the reporter, a few weeks after a procedure on the wrist the patient presented with negative reactivity to the suture in the wrist and hand region.An abscess had formed at the site of the suture and as a result the doctor removed the suture.The current patient status is fine and there were no long term effects.

• Brand Name: BIOSYN¿ MONOFILAMENT ABSORBABLE SUTURE 4-0 1.5 METRIC 18"
• 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5733929
• MDR Text Key: 47696912
• Report Number: 1219930-2016-00630
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SM5627
• Device Catalogue Number: SM5627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention