MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-10 for NEXCARE? FLEXIBLE CLEAR TAPE 771-1PK manufactured by 3m Health Care.
[178379289]
Event date: online review date used as the d. O. E. Product lot # not provided, therefore manufacture date is unknown. No sample or photos were provided to 3m for evaluation. Root cause of reported issue was not established. The 2-year complaint history was reviewed for the product's global sales code (gsc) of szp and reported failure. No trends were observed. 3m will continue to monitor. End of report.
Patient Sequence No: 1, Text Type: N, H10
[178379290]
A consumer reported via an online review that they applied the referenced tape. Date, duration and location of wear were not specified. The tape was reportedly used to secure gauze. The consumer alleged they developed contact dermatitis due to tape use. No known allergies/skin sensitivities were specified. The consumer reported they used prednisone to treat the reaction. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00009 |
| MDR Report Key | 9686583 |
| Report Source | CONSUMER |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-10 |
| 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 | BRYAN BECKER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 7375578 |
| Manufacturer G1 | 3M COMPANY BROOKINGS |
| Manufacturer Street | 601 22ND AVE SOUTH |
| Manufacturer City | BROOKINGS, SD |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXCARE? FLEXIBLE CLEAR TAPE |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2020-02-10 |
| Catalog Number | 771-1PK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-10 |