MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-07-03 for DR. SCHOLL'S DYNA STEP MEN'S REGULAR * manufactured by Schering-plough Healthcare Products.
[16764107]
A consumer reportedly had an unspecified reaction a month after the initiation of use of dynastep shoe inserts. The consumer reportedly required an operation that removed approximately half of consumer's right foot. After the surgical procedure, consumer reportedly required rehabilitation and plastic surgery. Consumer had not fully recovered approximately 9 months after the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031623-2001-00001 |
| MDR Report Key | 342382 |
| Report Source | 04 |
| Date Received | 2001-07-03 |
| Date of Report | 2001-05-22 |
| Date Mfgr Received | 2001-05-22 |
| Date Added to Maude | 2001-07-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 2000 GALLOPING HILL RD. |
| Manufacturer City | KENILWORTH NJ 07033 |
| Manufacturer Country | US |
| Manufacturer Postal | 07033 |
| Manufacturer Phone | 9739217435 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR. SCHOLL'S DYNA STEP |
| Generic Name | LIMB ORTHOSIS (SHOE INSERT) |
| Product Code | KNP |
| Date Received | 2001-07-03 |
| Returned To Mfg | 2001-07-13 |
| Model Number | MEN'S REGULAR |
| Catalog Number | * |
| Lot Number | DYN M-3270 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 331718 |
| Manufacturer | SCHERING-PLOUGH HEALTHCARE PRODUCTS |
| Manufacturer Address | 420 MICHIGAN AVENUE RD., NE CLEVELAND TN 37311 US |
| Baseline Brand Name | DYNASTEP INSERTS |
| Baseline Generic Name | INSERTS |
| Baseline Model No | NA |
| Baseline Catalog No | NA |
| Baseline ID | MEN'S REGULAR |
| Baseline Device Family | INSERTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-03 |