MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-01-21 for DR. SCHOLL'S CUSTOM FIT ORTHOTICS CF 310 manufactured by .
[5310815]
Event verbatim (lower level term). Knee surgery (knee operation). Case description: this spontaneous report originating from the united states as received from a consumer refers to a female pt of unk age. This report concerns 1 pt and 1 device. The pt used the orthotic (dr. Scholl's custom fit orthotics cf 310) for an unk indication. No other co-suspects were reported. No concomitant medications were reported. On an unk date, the pt had knee surgery (medically significant). No treatment info was reported. The action taken and the outcome were unk. The relatedness for the pt having knee surgery was unk for the orthotic (dr. Scholl's custom fit orthotics cf 310). The orthotic (dr. Scholl's custom fit orthotics cf 310) was not available for investigation. For the orthotic (dr. Scholl's customer fit orthotics cf 310), the lot number was not available and the serial number was not available. Add'l info was not expected.
Patient Sequence No: 1, Text Type: D, B5
[12973582]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1031623-2015-00001 |
| MDR Report Key | 4440109 |
| Report Source | 04 |
| Date Received | 2015-01-21 |
| Date of Report | 2015-01-14 |
| Date Mfgr Received | 2015-01-14 |
| Date Added to Maude | 2015-01-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | PO BOX 4 |
| Manufacturer City | WEST POINT PA 194860004 |
| Manufacturer Country | US |
| Manufacturer Postal | 194860004 |
| Manufacturer Phone | 2156527905 |
| Manufacturer G1 | MSD CONSUMER CARE, INC. |
| Manufacturer Street | 4207 MICHIGAN AVENUE RD. N.E. |
| Manufacturer City | CLEVELAND TN 37323 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37323 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR. SCHOLL'S CUSTOM FIT ORTHOTICS CF 310 |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2015-01-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-21 |