MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION BILAYER MATRIX WOUND DRESSING; BMWD

Catalog Number XXX-BWM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Seroma (2069); Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Journal of plastic, reconstructive & aesthetic surgery (2021) published: "bilayer wound matrix-based cutaneous scalp reconstruction: a multidisciplinary case control analysis of factors associated with reconstructive success and failure." background: scalp wounds pose reconstructive challenges due to the lack of skin elasticity, potential for compromised adjacent tissue, and desire for the restoration of esthetic contour.Bilayer wound matrix (bwm) has been successfully employed as a treatment modality for complex, full-thickness wounds of the scalp.We aimed to highlight risk factors for bwm success and failure in complex wounds of the scalp.Methods: a retrospective case-control study was performed from 2012 to 2019 of adult subjects who presented to plastic or dermatological surgery with complex scalp defects with or without exposed calvarium, who underwent staged reconstruction with bwm and split-thickness skin grafting or secondary intention.Success was defined as complete wound re-epithelialization within 90-day follow-up without additional operative procedures for wound coverage.Demographics, comorbidities, treatment history, wound characteristics, and clinical course were analyzed and correlated with reconstructive outcomes.Results: in total, 127 subjects were identified for inclusion, with mean age 74.6 ± 12.2 years, defect area 80.2 ± 89.4 cm2, and wound age 10.0 ± 65.4 days.Successful wound reconstruction occurred in 107 (84%) subjects.Postoperative wound infections were an independent predictor of bwm failure at 90 days (odds ratio: 6.4, 95% confidence interval: 1.5 - 26.7, and p<0.012).Additionally, subjects who underwent preoperative radiation were more likely to suffer from reconstructive failure (p<0.040) as well as those who require postoperative inpatient admission (p<0.034).Adverse events: 20 failures reportedly due to infection, seroma, hematoma, dehiscence, necrosis.Conclusion: bwm represents a reliable and efficacious modality in the treatment of complex scalp wounds.Patient comorbidities may not heavily influence the success of bwm to establish adequate wound coverage; however, preoperative radiation and postoperative wound infection may often lead to reconstructive failure.Https://doi.Org/10.1016/j.Bjps.2021.03.080.

Event Description

N/a.

Manufacturer Narrative

Bilayer wound matrix was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: BILAYER MATRIX WOUND DRESSING
• Type of Device: BMWD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14476639
• MDR Text Key: 294787449
• Report Number: 1121308-2022-00036
• Device Sequence Number: 1
• Product Code: KGN
• Combination Product (y/n): N
• PMA/PMN Number: K021792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-BWM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1