MAUDE Adverse Event Report: DJO, LLC DONJOY; PLAYMAKER, IROM, WRAP, POP, XL, BLACK

Model Number 11-0867-5

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

Patient Problem Cellulitis (1768)

Event Date 11/08/2016

Event Type  Injury  

Event Description

Complaint received that alleges "allergic reaction causing blisters and a rash".Questionnaire not received from customer or clinician.Additional data received from clinician and/or patient indicated; "they were traveling to (b)(6).During the flight (b)(6) noticed (b)(6)'s pants were wet in the area that covered the brace.He went to the hospital er upon arrival in (b)(6).He was released same day with a topical treatment.The following day he saw no improvement and went back.He was admitted and spent approximately 2 days (she doesn't recall specific length of stay) in the hospital for treatment.He suspects he is allergic the neoprene and has not worn the brace since then.Advised the reason he was admitted to hospital was that his initial allergic reaction that was treated as contact dermatitis had progressed and become cellulitis.He has had no further outbreaks."device not reviewed by manufacturer at this time.

• Brand Name: DONJOY
• Type of Device: PLAYMAKER, IROM, WRAP, POP, XL, BLACK
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663
• MDR Report Key: 6777148
• MDR Text Key: 82156200
• Report Number: 9616086-2017-00015
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-0867-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization