MAUDE Adverse Event Report: ETHICON INC. PDS FLEXIBLE PLATE; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Catalog Number ZFP8

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Wound Dehiscence (1154); Surgical procedure (2357)

Event Type  Injury  

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that a patient underwent a septoplasty procedure on (b)(6) 2014 and a flexible plate was implanted.Three weeks post septoplasty, the patient returned with a wound dehiscence in the septum.The patient required a second septoplasty on (b)(6) 2014.No additional information was provided.

Manufacturer Narrative

(b)(4) - wound dehiscence occurred.Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

Additional narrative: the indication for the procedure was a deviated nasal septum/hypertrophy nasal turbinates.The patient underwent a septoplasty/turbinate reduction procedure.The septum was removed.The patient was discharged (b)(6) 2014.

• Brand Name: PDS FLEXIBLE PLATE
• Type of Device: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-22 851; GM D-22851
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3839223
• MDR Text Key: 12230753
• Report Number: 2210968-2014-06831
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: ZFP8
• Device Lot Number: DH9BPKZO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2011
• 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 Weight: 175