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 BAND-AID? BRAND OF FIRST AID PRODUCTS SECURE-FLEX? WRAP 381371161508 manufactured by Johnson And Johnson Consumer Inc..
[112432857]
Device was used for treatment, not diagnosis. Udi number: (b)(4)/ upc = (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); labeling design - part of recall number z-1203-2018 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
[112432858]
This incident involves a (b)(6) male consumer using a band-aid brand first aid secureflex wrap (2 x 2. 5yd). The consumer reported using a band-aid brand first aid secureflex wrap to secure a traction device on his leg. The consumer started and stopped usage of the product on (b)(6) 2018 and topically applied the wrap once for 6-7 hours. The consumer reported the product irritated his skin, made it scratchy, stinging, and red. The consumer? S symptoms reduced after he stopped using the product. The consumer did self treat by applying bacitracin to the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00016 |
| MDR Report Key | 7639349 |
| Report Source | CONSUMER |
| Date Received | 2018-06-26 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-05-13 |
| Date Mfgr Received | 2018-05-14 |
| 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 | Z1203-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOHNSON & JOHNSON BAND-AID? BRAND OF FIRST AID PRODUCTS SECURE-FLEX? WRAP |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-06-26 |
| Model Number | 381371161508 |
| ID Number | (01)381371161508 |
| 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 | 1. Other | 2018-06-26 |