FDA Adverse Event Injury Summary report: N

UNKN PROFORE

MDR report key: 12013759 · Received June 16, 2021

Report

Report Number: 8043484-2021-01503
Event Type: Injury
Date Received: June 16, 2021
Date of Event: February 10, 2000
Report Date: September 20, 2021
Manufacturer: SMITH & NEPHEW MEDICAL LTD.
Product Code: FQM
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

H10: 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, REMOVAL, TIME LEFT ON PATIENT, TRAUMA, MATERIALS USED WITHIN THE DRESSING. THE INSTRUCTIONS FOR USE PROVIDE COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE. THE ASSOCIATED RISK FILES CONTAIN DETAILS RELATING TO HARM. HOWEVER, THE CLINICAL REVIEW HAS NOT ESTABLISHED A CAUSAL LINK. NO LOT/SERIAL NUMBER HAS BEEN PROVIDED THEREFORE A REVIEW IS NOT POSSIBLE. A COMPLAINT HISTORY REVIEW FOUND OTHER RELATED EVENTS. 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. H6: UPDATED CODES.

Description of Event or Problem · 1

ON THE LITERATURE ARTICLE NAMED "RANDOMISED TRIAL COMPARING TWO FOUR-LAYER BANDAGE SYSTEMS IN THE MANAGEMENT OF CHRONIC LEG ULCERATION", IT WAS REPORTED THAT 13 PATIENTS EXPERIENCED ADVERSE EVENTS ASSOCIATED TO PROFORE USE. 2 OF THOSE PATIENTS EXPERIENCED SIGNS OF INFECTION . NO ADDITIONAL INFORMATION ON POSSIBLE TREATMENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
906443	UNKN PROFORE	BANDAGE, ELASTIC	FQM	SMITH & NEPHEW MEDICAL LTD.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R