MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,08 report with the FDA on 2014-04-14 for STIMULAN RAPID CURE 620-010 manufactured by Biocomposites Ltd..
[4356280]
From a maude event report received at biocomposites inc on (b)(4) 2014 from the fda: voluntary report no. : (b)(4) had been received at fda via their medwatch program. Fda had forwarded the details to biocomposites inc. For review, as may have been unaware of the event.
Patient Sequence No: 1, Text Type: D, B5
[11748643]
Suspected root cause: serum creatine (a blood measurement) is an important indicator of renal health because it is an easily measured byproduct of muscle metabolism that is excreted unchanged by the kidneys. A serum creatinine of 1. 2mg/dl (110mcg/l) can indicate significant renal disease and systemic toxicity in an elderly female, as the kidney function is depleted. Certain drugs can sometimes cause abnormally elevated creatinine levels. Antibiotics were delivered iv- there is no link established to systemic levels from local delivery. The patient's reading had increased from 1 - normal to 1. 8 - high. Suspected root cause of high creatinine level is associated with renal failure, not stimulan rapid cure, which is contraindicated for renal compromised patients.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617083-2014-00013 |
| MDR Report Key | 3775739 |
| Report Source | 00,06,08 |
| Date Received | 2014-04-14 |
| Date of Report | 2014-03-20 |
| Date of Event | 2014-01-25 |
| Date Mfgr Received | 2014-03-20 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-04-29 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICHELLE HIRST |
| Manufacturer Street | KEELE SCIENCE PARK |
| Manufacturer City | STAFFORDSHIRE ST5 5NL |
| Manufacturer Country | UK |
| Manufacturer Postal | ST5 5NL |
| Manufacturer Phone | 440178233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIMULAN RAPID CURE |
| Generic Name | BONE VOID FILLER/ GRAFT EXTENDER |
| Product Code | MBP |
| Date Received | 2014-04-14 |
| Catalog Number | 620-010 |
| Lot Number | 08/13-R192 |
| Device Expiration Date | 2015-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPOSITES LTD. |
| Manufacturer Address | KEELE, STAFFORDSHIRE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-04-14 |