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 HURT-FREE? WRAP 381371161454 manufactured by Skillman Contract.
[112846823]
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. 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-1205-2018. 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
[112846824]
A (b)(6) female patient, (b)(6) reported that in november she used a band aid hurt free wrap and had an allergic reaction to her skin. She put the wrap on after her procedure and her skin began to itch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00017 |
| MDR Report Key | 7639400 |
| 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 NH 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 | Z1205-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOHNSON & JOHNSON BAND-AID? BRAND OF FIRST AID PRODUCTS HURT-FREE? WRAP |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-06-26 |
| Model Number | 381371161454 |
| ID Number | (01)381371161454 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKILLMAN CONTRACT |
| Manufacturer Address | 199 GRANDVIEW ROAD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |