MAUDE Adverse Event Report: AVERY DENNISON CORPORATION RELIATECT(TM) POST-OP DRESSING WITH CHG; DRESSING, WOUND, DRUG

Model Number MED 9903MS OR MED 9904MS

Device Problem Sticking (1597)

Patient Problem Suture Abrasion (2497)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

A clinician reported that the device adhered to the skin and removed the dermabond.It was also noted that the dressing stuck to the suture tails at the end of the incision pulling up the scabs and causing the incision to bleed.No medical intervention was reported.The part number and lot number were not provided for the complaint.Therefore, both sizes of the post-op dressings were evaluated as part of the complaint investigation.Since this conservative approach was employed, all production lots shipped within the complaint time frame were treated as suspect and evaluated.Based on the nature of the incident, retain samples were tested for adhesion and related performance characteristics.All the results were found to be within specifications.In addition, avery dennison conducted a device history record review for all suspected lots.The review confirmed that the performance characteristics were within specification at the time of product release.It is also important to note that the ifu for the concomitant skin closure device states that a dry wound dressing, such a gauze, may be applied after the adhesive has been completely polymerized.The reliatect(tm) is not considered a dry wound dressing.

Event Description

A clinician reported that the dressing removed the dermabond on the incision site and pulled at the scabs causing the incision to bleed.

• Brand Name: RELIATECT(TM) POST-OP DRESSING WITH CHG
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): AVERY DENNISON CORPORATION; 7100 lindsay drive; mentor OH 44060
• Manufacturer (Section G): AVERY DENNISON CORPORATION; 7100 lindsay drive; mentor OH 44060
• Manufacturer Contact: lisa bartakovics ; 20 north wacker drive; suite 2240; chicago, IL 60606 ; 3122066159
• MDR Report Key: 7445080
• MDR Text Key: 106003336
• Report Number: 3003764829-2018-00004
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 04/17/2019
• Device Model Number: MED 9903MS OR MED 9904MS
• Device Catalogue Number: 0496-0567-76 OR 0496-0568-76
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 40 YR