MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-09 for J&J COACH SELF ADHERING SPORTS WRAP USA 381370079286 manufactured by Johnson & Johnson Consumer Inc.
[116602272]
Device was used for treatment, not diagnosis. Patient information was not provided for reporting. (b)(4). Expiration date = na. Lot number = not reported. Device is not expected to be returned for manufacturer review/investigation.? 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). 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
[116602273]
Consumer reported that the consumer purchased coach self-adhering elastic bandage 2 inch x 2. 2 yards 1-count (pack of 3) in 2011.? Consumer alleged having some reactions for many years.? Consumer reported having hives every day.?? There is no indication that the consumer sought medical treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00037 |
| MDR Report Key | 7767974 |
| Report Source | CONSUMER |
| Date Received | 2018-08-09 |
| Date of Report | 2018-07-21 |
| Date Mfgr Received | 2018-07-21 |
| Date Added to Maude | 2018-08-09 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z1201-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J&J COACH SELF ADHERING SPORTS WRAP USA |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-08-09 |
| Model Number | 381370079286 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER INC |
| Manufacturer Address | 199 GRANDVIEW ROAD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-09 |