MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-10-15 for DR SCHOLL'S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH manufactured by .
[5094599]
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 (b)(6)s pain relief orthotics (pro) for arch, womens) for an unk indication. No other co-suspects were reported. No concomitant medications were reported. On an unk date the pt experienced an accident which caused her to have multiple fractures of the orbital bone of her left eye and a broken nose (medically significant). She had many sprains and a great deal of pain, and she further reported that she has post-concussion syndrome causing loss of balance and headaches. No treatment info was reported. The action taken on the product was unk. The outcome of the pt's multiple fractures of the orbital bone, broken nose, accident, headaches, pain, sprains and loss of balance were unk. The outcome of the pt's post-concussion syndrome was reported as not recovered/not resolved. The pt's multiple fractures of the orbital bone, broken nose, headaches, loss of balance, post-concussion syndrome, pain, sprains and accident were considered to be not related to the orthotic (dr (b)(6)'s pain relief orthotics (pro) for arch, womens). The reporter considered the product not helping to be related to the orthotic (dr (b)(6)'s pain relief orthotics (pro) for arch, womens). The orthotic (dr (b)(6)'s pain relief orthotics (pro) for arch, womens) was available for the investigation. For the orthotic (dr (b)(6)'s pain relief orthotics (pro) for arch, womens), the lot number was not available and the serial number was not available. Additional info was not expected.
Patient Sequence No: 1, Text Type: D, B5
[12492607]
Post concussion syndrome (post concussion syndrome), loss of balance (equilibrium loss), sprains (sprain), great deal of pain (pain), headaches (headache), accident (accident), not helpful to me (therapeutic product ineffective). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1031623-2014-00011 |
| MDR Report Key | 4184040 |
| Report Source | 04 |
| Date Received | 2014-10-15 |
| Date of Report | 2014-10-06 |
| Date Mfgr Received | 2014-10-06 |
| Date Added to Maude | 2014-10-21 |
| 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 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 PAIN RELIEF ORTHOTICS (PRO) FOR ARCH |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE (KNP) |
| Product Code | KNP |
| Date Received | 2014-10-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-15 |