MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-26 for FLENTS 69622 manufactured by Apothecary Products Llc.
[186518764]
Customer stated that finger splint cut her son's thumb. He was at school and someone bumped into him and the splint caused a cut that required two stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183416-2020-00002 |
| MDR Report Key | 9756344 |
| Report Source | CONSUMER |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-25 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-26 |
| 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 | MR. RUSS DAVIES |
| Manufacturer Street | 11750 12TH AVENUE SOUTH |
| Manufacturer City | BURNSVILLE, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 8088365 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLENTS |
| Generic Name | FINGER SPLINT |
| Product Code | NOC |
| Date Received | 2020-02-26 |
| Model Number | 69622 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOTHECARY PRODUCTS LLC |
| Manufacturer Address | 11750 12TH AVENUE SOUTH BURNSVILLE, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |