MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-30 for J&J COACH SELF ADHERING SPORTS WRAP 381370079286 manufactured by Johnson & Johnson Consumer Inc.
[118871097]
Device was used for treatment, not diagnosis. Patient ethnicity and race was not provided for reporting. (b)(4). Expiration: na. Lot number: 2547car. Device is not expected to be returned for manufacturer review/investigation. Concomitant medical products and therapy dates: drug: cetirizine; 10 mg, 1x daily; 3 years; to treat allergies; consumer still on drug. Drug: other unknown medications. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review have been requested. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[118871098]
A (b)(6), female consumer reported that she used johnson and johnson coach self adhering sports wrap for the first time on (b)(6) 2018 for a sprained ankle. Consumer reported that she wrapped her sprained ankle with the product for up to 12 hours. Within the same day, the consumer started to experiencing irritation around her ankle and wearing the product started to get uncomfortable and removed the product. On (b)(6) 2018, the affected area was irritated, itchy and had blisters all around the ankle where the product was wrapped. Consumer reported she did not medically treat the area but did indicate she kept the area clean until she saw her podiatrist who diagnosed her with contact dermatitis. The hcp prescribed the consumer to apply fluocinonide cream to the affected area as a treatment. Consumer reported she applied the fluocinonide cream as needed. Consumer reported that her symptoms are resolving but does still experience some irritation and on occasion will have itching in the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00043 |
| MDR Report Key | 7834685 |
| Report Source | CONSUMER |
| Date Received | 2018-08-30 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2017-09-11 |
| Date Added to Maude | 2018-08-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152737120 |
| Manufacturer G1 | CAREMAX |
| Manufacturer Street | NO. 43, SHUANG JING STREET FENG TING RD |
| Manufacturer City | SIP, JIANGSU, P.R. 215121 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J&J COACH SELF ADHERING SPORTS WRAP |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-08-30 |
| Model Number | 381370079286 |
| Lot Number | 2547CAR |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER INC |
| Manufacturer Address | 199 GRANDVIEW RD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-30 |