MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number 16306

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A surgeon reported the drape was too sticky and it caused the patient's skin to tear and bleed at the cheekbone when it was removed at the end of a surgical procedure.The surgeon prescribed an iodine solution as well as he closed the wound with gauze.No additional information is expected.

Manufacturer Narrative

(b)(4).

Event Description

The patient's torn skin has resolved with no complications.

Manufacturer Narrative

There have been no additional complaints reported against the finished goods lot and the device history record shows the product was released per specifications.The customer complained that the adhesive portion of the drape is too sticky and that it caused the patient¿s skin to scratch, tear and bleed when removing after surgery.The sample was discarded after surgery.When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.Action will not be taken for this occurrence.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.Manufacturing management and quality engineering materials will be made aware of this complaint through the monthly complaint review meeting.(b)(4).

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7297234
• MDR Text Key: 100964306
• Report Number: 1644019-2018-00038
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2020
• Device Catalogue Number: 16306
• Device Lot Number: 2079034H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• 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
• Treatment: UNSPECIFIED DRAPE
• Patient Outcome(s): Other; Required Intervention