MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD PTFE POLYMER PLEDGETS; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number 88868677-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the survey conducted for wound suture, a pledget migration was observed on 2 patients - which was related to loose stitches and badly positioned pledgets.

• Brand Name: PTFE POLYMER PLEDGETS
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8895494
• MDR Text Key: 154360972
• Report Number: 9612501-2019-01565
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 10884521104617
• UDI-Public: 10884521104617
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K953289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88868677-01
• Device Catalogue Number: 88868677-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/14/2019
• 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
• Patient Outcome(s): Other