MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. KCI® NPWT GAUZE DRESSING; OMP

Model Number VACDSP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged reaction is related to the kci® npwt gauze dressing.The patient has known allergies to medications and thus may be prone to allergic reactions to other foreign substances.Device labeling, available in print and online, states: warnings sensitivity to phmb: the kerlix¿ amd¿ super sponges contain phmb, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to phmb.If a patient has a known allergy or hypersensitivity to phmb, do not use kci® npwt gauze dressings.If any signs of allergic reaction or hypersensitivity develop, such as redness, swelling, rash, uticaria or significant pruritis, discontinue use and consult a physician immediately.If bronchospasm or more serious signs of allergic reaction appear, seek immediate medical assistance.

Event Description

On (b)(6) 2018, the following information was reported to kci by the nurse: the patient had the activ.A.C.¿ therapy system placed and subsequently experienced a rash.The activ.A.C.¿ therapy system was discontinued.The patient reportedly has three known allergies to antibiotics.The nurse alleged that the phmb [polyhexamethylene biguanide] in the dressing may have caused the event.On (b)(6) 2018, the following information was provided to kci by the nurse: on (b)(6) 2018, the patient was placed on the activ.A.C.¿ therapy system with amd gauze.¿while the procedure was initiated, the patient began to cough and became slightly short of breath.The vac was switched on and then an erythaematous rash began radiating out from the pressure ulcer area to his upper body and legs.He [patient] had not taken any medication prior to the vac being set up.¿ the rash allegedly radiated from the patient's wound and the patient¿s symptoms improved and subsided after the activ.A.C.¿ therapy system was removed.The patient received intramuscular and oral antihistamine treatment.The kci® npwt gauze dressing lot number is unknown, therefore a device history review could not be performed.

Event Description

On jul 04 2018, kci quality engineering performed a device history review of kci® npwt gauze dressing lot number 17eo72562 that determined there were no nonconformances identified or deviations used during the manufacture of this lot.All end release testing of product and packaging met specifications.The information of a specific patient allergy to phmb [polyhexamethylene biguanide] was not provided to kci.

Manufacturer Narrative

Based on the additional information obtained regarding the disposable, kci's assessment remains the same; it cannot be determined that the alleged reaction is related to the kci® npwt gauze dressing.

Event Description

On 10 sep 2018, kci quality engineering performed a device history review of kci® npwt gauze dressing lot number 17eo72562 which provided the kci® npwt gauze dressing expiration date of 01 jun 2022.

Manufacturer Narrative

Correction: mdr-3009897021-2018-00052 fu1 sent on 24 jul 2018 noted device manufacturing date: 11 dec 2017.Should be blank as the device manufacturing date is unknown.Based on the additional information obtained regarding the disposable, kci's assessment remains the same; it cannot be determined that the alleged reaction is related to the kci® npwt gauze dressing.

• Brand Name: KCI® NPWT GAUZE DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• MDR Report Key: 7557629
• MDR Text Key: 109709003
• Report Number: 3009897021-2018-00052
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K123507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: VACDSP
• Device Lot Number: 17EO72562
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR