MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-07-14 for DR. SCHOLL'S MASSAGING GEL HEEL CUPS manufactured by .
[17396913]
A (b)(4) serious device report was received by a company representative regarding a male consumer. Concomitant medications were unknown. Medical history was not provided. The company representative reported the consumer's wife had spoken to the company representative's wife and stated the consumer had used (b)(4) massaging gel heel cups. Frequently of use and indication for product use were not provided. The company representative stated he "guessed" the product had "caused some blister on his foot" which "became infected". He additionally stated the consumer eventually had a toe amputated. The company representative was not sure if this was a direct cause and effect. No additional information was provided. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031623-2010-00001 |
| MDR Report Key | 1883098 |
| Report Source | 04 |
| Date Received | 2010-07-14 |
| Date of Report | 2010-06-15 |
| Date Mfgr Received | 2010-06-15 |
| Date Added to Maude | 2010-10-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEAN MAZET |
| Manufacturer Street | 556 MORRIS AVENUE |
| Manufacturer City | SUMMIT NJ 07901 |
| Manufacturer Country | US |
| Manufacturer Postal | 07901 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR. SCHOLL'S MASSAGING GEL HEEL CUPS |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KYS |
| Date Received | 2010-07-14 |
| 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 | 2010-07-14 |