MAUDE Adverse Event Report: COVIDIEN BIOSYN* 3/0 27 UNDYED C-14; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number SM693

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, approximately two to three weeks post-brachioplasty, the patient has experienced the wounds opening and the sutures coming through the incision.The patient is treating the wounds with hydrogen peroxide, saline washes, and wraps.The wounds appear red and inflamed but not infected.No culture was performed.The issue has not yet resolved.

• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6300052
• MDR Text Key: 66462632
• Report Number: 9612501-2017-00206
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SM693
• Device Catalogue Number: SM693
• Device Lot Number: D5A1040X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• 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): Other
• Patient Age: 68 YR