MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for JOHNSON & JOHNSON COACH? SELF-ADHERING SPORTS WRAP 381370079293 manufactured by Johnson And Johnson Consumer Inc..
[112447943]
Device was used for treatment, not diagnosis. Ethnicity/race was not reported. (b)(4). Expiration date = na. Lot number = not reported. Device is not expected to be returned for manufacturer review/investigation. Concomitant medical products and therapy dates: alotapine, 5mg day, has been taking for years to treat high blood pressure levothyroxin, 0. 100mg day, has been taking for years to treat hypothyroidism synthroid, 20mg day, has been taking for years to treat high cholesterol device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without a lot number. (b)(4). Part of recall number z-1202-2018. 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
[112447944]
A (b)(6) caucasian female consumer reported that she has been using the j&j coach self adhering sports wrap since (b)(6) 2017 for wound care. Consumer stated that since use of the wrap she noticed a redness on her skin where the wrap contacts the skin. Consumer was not aware if she has a latex allergy. She did not have any other allergies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00012 |
| MDR Report Key | 7638481 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-08-21 |
| Date Mfgr Received | 2018-08-21 |
| 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, P.R. 215121 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z1202-2018 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JOHNSON & JOHNSON COACH? SELF-ADHERING SPORTS WRAP |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-06-26 |
| Model Number | 381370079293 |
| ID Number | (01)381370079293 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON AND JOHNSON CONSUMER INC. |
| Manufacturer Address | 199 GRANDVIEW ROAD SKILLMAN NJ 088589418 US 088589418 |
| Brand Name | JOHNSON & JOHNSON COACH? SELF-ADHERING SPORTS WRAP |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-06-26 |
| Returned To Mfg | 2018-08-21 |
| Model Number | 381370079293 |
| ID Number | (01)381370079293 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |