MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-22 for * UNK manufactured by Unk.
[344942]
Pt has been wearing a support belt for a back problem since 2001. The support belt collapsed and pt underwent fusion of the disc. Surgery did not hold and pt was on demerol for pain the intensity of the pain increased and pt could not walk alone except with crutches. Pt was bent over. Pt was given a blocking injection and later developed tarlov cyst. Referred to another facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034705 |
| MDR Report Key | 576467 |
| Date Received | 2005-02-22 |
| Date of Report | 2005-02-22 |
| Date of Event | 2002-10-28 |
| Date Added to Maude | 2005-03-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | IDET |
| Product Code | ISR |
| Date Received | 2005-02-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 566305 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2005-02-22 |