MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN CUTICERIN; DRESSING, WOUND, DRUG

Catalog Number UNKN05002000

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that, during burn treatment, a combination of an unknown cuticerin dressing and an unknown jelonet dressing was not easily applied.Patient reported that dressing residues kept sticking to the wound and the dressing comes loose.As this was noticed in a retrospective post market clinical follow up activity, further information is not available.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include application and or product failure.No batch/lot number has been provided, therefore a review of the device history has not been possible the complaint history file contains no further instances.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include application and or product failure.No batch/lot number has been provided, therefore a review of the device history has not been possible.The complaint history file contains no further instances.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Event Description

It was reported that, during burn treatment, an unknown cuticerin dressing was not easily applied.Patient reported that dressing residues kept sticking to the wound and the dressing comes loose.As this was noticed in a retrospective post market clinical follow up activity, further information is not available.

• Brand Name: UNKN CUTICERIN
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11880985
• MDR Text Key: 252929470
• Report Number: 8043484-2021-01196
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1