MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-29 for HARRINGTON ROD manufactured by Unk07/01/1978.
[61223140]
Neurogenic bladder. Harrington rod implanted (b)(6) 1978. (b)(6) 2015, i had a ct scan for possible ovarian cancer, the rod was discovered broken at this time. Prior to that, i began having pain, numbness and weakness down the left leg along with bladder incontinence. I am a (b)(6) female now. I'm a nurse and unable to perform my job at the high level i could previously due to pain and numbness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066425 |
| MDR Report Key | 6136192 |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-29 |
| Date of Event | 2015-05-01 |
| Date Added to Maude | 2016-11-30 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HARRINGTON ROD |
| Generic Name | HARRINGTON ROD |
| Product Code | PGM |
| Date Received | 2016-11-29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK07/01/1978 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-11-29 |