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 381370079293 manufactured by Johnson & Johnson Consumer Inc.
[112865359]
. device was used for treatment, not diagnosis . udi number: (b)(4) . upc = (b)(4) . expiration date = na, lot number = (10)1197ca . device is not expected to be returned for manufacturer review/investigation . concomitant medical products and therapy dates: drug: levothyroxin 0 .100mg a day; unknown timeframe; for hypothyroidism; consumer still on drug . drug: alotapine 5mg a day: unknown timeframe; for high blood pressure; consumer still on drug . drug: synthroid 20mg a day: unknown timeframe; for high cholesterol; consumer still on drug . a review of the device history records has been requested . device evaluation/investigation could not be completed; no conclusion could be drawn at this time as product was not returned to manufacturer . (b)(4) labeling design - 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
[112865360]
A (b)(6) year old 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 | 2214133-2018-00015 |
| MDR Report Key | 7638788 |
| Report Source | CONSUMER |
| Date Received | 2018-06-26 |
| Date of Report | 2018-08-21 |
| Date Mfgr Received | 2018-08-21 |
| Device Manufacturer Date | 2017-04-29 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z1202-2018 |
| 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 |
| Returned To Mfg | 2018-08-21 |
| Model Number | 381370079293 |
| Lot Number | 1197CA |
| 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 & JOHNSON CONSUMER INC |
| Manufacturer Address | 199 GRANDVIEW RD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |