MAUDE Adverse Event Report: QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. DRAPE OPHTHALMIC INCISE W/POUCH; DRAPE, PATIENT, OPHTHALMIC

Catalog Number D1061

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Peeling (1999); No Information (3190)

Event Date 05/04/2017

Event Type  Injury  

Manufacturer Narrative

Cardinal health is proactively filing this complaint.The device history record (dhr) was reviewed and no quality issues were reported.An evaluation of the returned representative sample was completed for material, folds, pouch and finished dimensions.No defects were found.Based on the evaluation of the sample and the dhr, the issue of aggressive adhesive was not confirmed.In addition, all finished goods are made from qualified materials that are tested before use.Final finished product must meet product specification and process requirements before final release to salable inventory.A root cause was not determined and no corrective action was taken.We will continue to monitor for complaints of this nature.

Event Description

Received complaint that stated the adhesive on the drape was too strong, and peeled the skin and ripped eye lashes off when removing.The complaint was originally received in may, and multiple attempts were made to obtain information from the customer, however the end user did not respond.On (b)(6) the customer reported that the end user had contacted them with information that antibiotic ointment and steroids were used for peeled skin; and that skin and lashes are ok now.The customer reported that they doubted there would be any further specific information from the end user.

• Brand Name: DRAPE OPHTHALMIC INCISE W/POUCH
• Type of Device: DRAPE, PATIENT, OPHTHALMIC
• Manufacturer (Section D): QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.; av. rio chuviscar y carretera; cuauhtemoc, chihuahua 31543 ; MX 31543
• Manufacturer (Section G): QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.; av. rio chuviscar y carretera; cuauhtemoc, chihuahua 31543 ; MX 31543
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6778502
• MDR Text Key: 82400143
• Report Number: 1423537-2017-00120
• Device Sequence Number: 1
• Product Code: HMT
• UDI-Device Identifier: 10885380061066
• UDI-Public: 10885380061066
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/01/2020
• Device Catalogue Number: D1061
• Device Lot Number: 15DBC127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other