MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-12-29 for DR.SCHOLL'S HEEL PAIN RELIEF ORTHOTICS - MEN manufactured by .
[15320726]
Event verbatim (lower level term). Had a heart attack. The underside purple circle came out (product quality issue). Case description: this spontaneous report originating from the united states as received from a consumer refers to a male patient of unknown age. This report concerns 1 patient and 1 device. The patient used the orthotic (dr. Scholl's heel pain relief orthotics - men's) for an unknown indication. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient had a heart attack (medically significant) and the underside purple circle came out. No treatment information was reported. The orthotic (dr. Scholl's heel pain relief orthotics - men's) was discontinued. The outcome of the events was unknown. The reporter considered the underside purple circle coming out to be not related to the orthotic (dr. Scholl's heel pain relief orthotics - men's).
Patient Sequence No: 1, Text Type: D, B5
[15549203]
(b)(4). The relatedness for the patient having a heart attack was unknown for the orthotic (dr. Scholl's heel pain relief orthotics - men's). The orthotic (dr. Scholl's heel pain relief orthotics - men's) was not available for investigation. For the orthotic (dr. Scholl's heel pain relief orthotics - men's), the lot number was not available and the serial number was not available. Additional information was not expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1031623-2014-00013 |
| MDR Report Key | 4379911 |
| Report Source | 04 |
| Date Received | 2014-12-29 |
| Date of Report | 2014-12-16 |
| Date Mfgr Received | 2014-12-16 |
| Date Added to Maude | 2015-01-14 |
| 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 Contact | MERCK |
| Manufacturer Street | P.O 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 HEEL PAIN RELIEF ORTHOTICS - MEN |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2014-12-29 |
| 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 | 2014-12-29 |