MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN PROFORE; BANDAGE, ELASTIC

Catalog Number UNKN05001801

Device Problem Biocompatibility (2886)

Patient Problem Anaphylactic Shock (1703)

Event Date 07/21/2023

Event Type  Injury  

Manufacturer Narrative

Internal reference number (b)(4).

Event Description

It was reported that, after a debridement, following the application of a wound contact layer from a s+n compression wrap kit, the patient experienced an anaphylactic shock.The patient is allergic to adhesives and suspects a different, unsterile product (4x4 + tape) was applied.It is unknown how treatment was finished.It is unknown how the incident was resolved.The patient is still suffering.

Manufacturer Narrative

H3, h6: the product was not returned for evaluation, so analysis of a physical sample was not possible.A review of batch records was not possible for this event, as a definitive product or batch number was not provided with the complaint detail.A specific product was not identified in this complaint, so a review of previous complaints against all profore products was performed.It was found that there are no other reports of allergic reactions or anaphylactic responses to any profore dressings.There are no previous relevant escalation actions in place in relation to this product and failure mode combination.The product instructions/guidance for use does not offer any insight into how the reported event may have occurred.There are no specific instructions in relation to potential allergic reactions to any of the components of the dressing or wound contact layer.A review of the risk files associated with profore dressings was performed.Sensitisation reactions are adequately covered within the risk files, meaning no changes are required to risk documentation for this product.A medical review was also conducted for the reported event, which concluded that the information provided is insufficient to determine whether the reported anaphylactic shock was due to a pre-existing allergy or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the wound contact layer from the s&n compression wrap kit, one or more of its components, or its intended therapeutic action.Probable cause of the reported event is, as stated above, that the patients reaction may have been a result of pre-existing allergy to the product, or another adhesive product that was used in treatment.No manufacturing quality concerns have been confirmed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.

• Brand Name: UNKN PROFORE
• Type of Device: BANDAGE, ELASTIC
• 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: 17446982
• MDR Text Key: 320279264
• Report Number: 8043484-2023-00053
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNKN05001801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female