MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD UNKNOWN SUTURE PRODUCT; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number UNKNOWN SUTURE PRODUCT

Device Problems Entrapment of Device (1212); Product Quality Problem (1506); Dull, Blunt (2407)

Patient Problem No Information (3190)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, intra-operatively, the needle was dull after throwing 3 stitches and also was straightened out while closing skin on ankle and would not go through the skin.

• Brand Name: UNKNOWN SUTURE PRODUCT
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8606256
• MDR Text Key: 144946326
• Report Number: 9612501-2019-00955
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SUTURE PRODUCT
• Device Catalogue Number: UNKNOWN SUTURE PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/13/2019
• 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