MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-26 for JOHNSON & JOHNSON COACH? SELF-ADHERING SPORTS WRAP manufactured by Johnson And Johnson Consumer Inc..
[112437282]
Device was used for treatment, not diagnosis. This report is for two (2) unknown j&j coach self adhering sports wraps, lot # and udi# is not available (b)(4). Part of recall numbers z-1201-2018 & z-1202-2018 recall: this report is for two (2) unknown j&j coach self adhering sports wraps: z-1201-2018 - coach? Self-adhering sports wrap (size: 2in) z-1202-2018 - coach? Self-adhering sports wrap (size: 3in) 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
[112437283]
A male consumer reported that after using two unknown coach self adhering sports wraps, one time, on both his ankles he got a rash. Consumer stated that he started use on (b)(6) 2017 and stopped use on (b)(6) 2017. Consumer first noticed the rashes on (b)(6) 2017 and he has fully recovered from the event on (b)(6) 2017. He self -treated with over the counter lotion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00018 |
| MDR Report Key | 7639511 |
| Report Source | CONSUMER |
| Date Received | 2018-06-26 |
| Date of Report | 2018-01-04 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2018-01-04 |
| Date Added to Maude | 2018-06-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 215121 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215121 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z1201-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOHNSON & JOHNSON COACH? SELF-ADHERING SPORTS WRAP |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-06-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON AND JOHNSON CONSUMER INC. |
| Manufacturer Address | 199 GRANDVIEW ROAD SKILLMAN NJ 088589418 US 088589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |