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 & Johnson Consumer Inc.
[112870719]
(b)(4). Lot number = unknown. 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 lot number. (b)(4) - 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
[112870720]
Consumer reported some itching and red bumps after using johnson and johnson band-aid secure flexcare wrap. Consumer, started using them (b)(6) 2017 and is still using them. Additionally, to treat the itching and bumps consumer used hydrocortisone cream and put the wrap over a sock. Consumer is using it for pain caused by erythema and small vesicles and does consider himself recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00014 |
| MDR Report Key | 7638709 |
| Report Source | CONSUMER |
| Date Received | 2018-06-26 |
| Date of Report | 2018-01-04 |
| 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, 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 & JOHNSON CONSUMER INC |
| Manufacturer Address | 199 GRANDVIEW ROAD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |