MAUDE Adverse Event Report: ETHICON INC. PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE; SUTURE, SURGICAL, ABSORBABLE

Catalog Number PDP316H

Device Problem Needle, separation (1415)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a mammoplasty on (b)(6) 2014 and suture was used.During the procedure, the needle pulled off.Another like device was used to complete the procedure with no adverse patient consequences.

Manufacturer Narrative

Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3916282
• MDR Text Key: 4488597
• Report Number: 2210968-2014-08699
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K061037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PDP316H
• Device Lot Number: EMZ005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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