MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD; SUTURE, ABSORBABLE, NATURAL

Model Number G1758

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/21/2017

Event Type  Injury  

Event Description

According to the reporter, during a dacryocystorhinostomy (open eye surgery).The suture was staying around too long and would not absorb fast enough 3 weeks post opp.Another suture that they had absorbed faster, this required another operation (8 weeks later) to remove the nasal stent that was sutured with the suture.Patient is fine.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, per additional information received patient is fine.There was no tissue damage or adverse events reported.

Manufacturer Narrative

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

• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6619588
• MDR Text Key: 76939178
• Report Number: 9612501-2017-05593
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G1758
• Device Catalogue Number: G1758
• Device Lot Number: D5B249X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• 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: 60 YR
• Patient Weight: 54