MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2019-08-22 for DR SCHOLLS CUSTOM FIT ORTHOTIC INSERTS CF 440 manufactured by Bayer Healthcare Llc, Consumer Care.
| Report Number | 2248903-2019-00003 |
| MDR Report Key | 8922222 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2019-08-22 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-08-16 |
| Date Added to Maude | 2019-08-22 |
| 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 | K. LAMBERSON |
| Manufacturer Street | 100 BAYER BLVD. P.O. BOX 915 |
| Manufacturer City | WHIPPANY NJ 079810915 |
| Manufacturer Country | US |
| Manufacturer Postal | 079810915 |
| Manufacturer G1 | BAYER HEALTHCARE LLC, CONSUMER CARE |
| Manufacturer Street | 36 COLUMBIA RD. |
| Manufacturer City | MORRISTOWN NJ 07960 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR SCHOLLS CUSTOM FIT ORTHOTIC INSERTS CF 440 |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE LIMB ORTHOSIS |
| Product Code | KNP |
| Date Received | 2019-08-22 |
| Model Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER HEALTHCARE LLC, CONSUMER CARE |
| Manufacturer Address | 36 COLUMBIA RD. MORRISTOWN NJ 07960 US 07960 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-22 |