MAUDE Adverse Event Report: COVIDIEN CURITY; TAPE AND BANDAGE, ADHESIVE

Model Number	44101-
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the adhesive was stickier than normal.It wasn't coming out easily.When the patient removed it finally, it discolored her skin and left a dark patch on the skin which came in contact with the adhesive.
Additional Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the customer reported the adhesive was stickier than normal.It wasn't coming out easily.When the patient removed it finally, it discolored her skin and left a dark patch on the skin which came in contact with the adhesive.¿ a review of the device history record (dhr) for lot no.B1710182 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Samples were received for evaluation.No abnormalities were identified.Ten (10) production retained samples lot b1710182 were also evaluated by the supplier.The production retains were visually inspected.The peel strength test was performed on the retention samples and all test values are qualified according to the adhesion to steel test report.In addition, peel strength test records of finished product also observed no abnormalities.Biocompatibility studies conducted by a third party lab for this product revealed the product passed the test requirements for bio compatibility.Incoming quality control records for glue resulted in no abnormalities.The coating machine daily production records were also reviewed with no abnormalities identified.The reported customer complaint could not be confirmed.A root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CURITY
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7561064
• Report Number: 1282497-2018-00441
• Device Sequence Number: 1775360
• Product Code: FQM
• UDI-Device Identifier: 10884521144477
• UDI-Public: 10884521144477
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 44101-
• Device Catalogue Number: 44101-
• Device Lot Number: B1710182
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 04/26/2019
• Patient Sequence Number: 1