MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-04 for CAPHOSOL manufactured by Eusa Pharma (us) Llc.
[129168814]
The provided qa analysis is an intermediate report only pending finalised report.
Patient Sequence No: 1, Text Type: N, H10
[129168815]
Hospitalized for swollen tongue and couldn't swallow [swollen tongue]. Hospitalized for swollen tongue and couldn't swallow [dysphagia]. This spontaneous incident report was received by eusa pharma on 02-aug-2018 via the fda medical device regulatory services from a pharmacist in the united states, who was contacted by the patient's wife. A male patient (age, date of birth, ethnicity and race unknown) with a history of cancer of the tongue (onset date unknown) received caphosol (calcium phosphate) (lot:7111 and 17108, expiration date unknown) orally, frequency reported as up to 10 days, dose or amount reported as mix: blue 1 clear, from unknown date for malignant neoplasm of base of the tongue. Concomitant medications included ropinirole, lyrica (pregabalin), zoloft (sertraline), lorazepam, oxycodone (indications and start/stop dates were not reported). On (b)(6) 2018, the patient experienced swollen tongue and was unable to swallow. At the time of the report, the patient had been hospitalised for the reported events since an unknown date in 2018. The reporter did not report the causality between caphosol (calcium phosphate) and the reported events. Further information is expected. Follow-up information received on 31-aug-2018 included an intermediate report about the evaluation of the product complaint and the root cause analysis. Initial classification of complaint: critical. Evaluation of complaint and root cause analysis: batch 17111 (caphosol a) has been manufactured on 18/01/2017, expiry date 01/2020. (b)(4). Batch has been reviewed and no anomaly which will be explain this case has been found. The solution has been manufactured according to internal specifications and shows no deviation. The cleaning carried out before this preparation is done with water. The storage time and the distribution time have been respected. The filters used for the distribution of the solution are compliant. Sterilizing filtration is compliant. Aerobio contamination controls during manufacturing are consistent, as are sterility and chemical results. Batch 17108 (caphosol b) has been manufactured on 20/01/2017, expiry date 01/2020. (b)(4). Batch has been reviewed and no anomaly which will be explain this case has been found. The solution has been manufactured according to internal specifications and shows no deviation. The cleaning carried out before this preparation is done with water. The storage time and the distribution time have been respected. The filters used for the distribution of the solution are compliant. Sterilizing filtration is compliant. Aerobio contamination controls during manufacturing are consistent, as are sterility and chemical results. Batch 17111/17108 (b)(4) (impacted by this complaint) has been packaged on 10/07/2017. (b)(4) units were produced for us market ((b)(4)). 2 deviations were raised during the packaging process but without impact on the quality of the product (d170253 and d170254). All stocks have been sold. Batch 17111/17108 (b)(4) has been packaged on 26/07/2017. (b)(4) units were produced for us market ((b)(4)). Remaining in stock: (b)(4) units at (b)(6) and (b)(4) units at (b)(6). Impact analysis: no other batches impacted by this complaint. It is the first complaint of this type since january 2017. 4 complaints were registered for the batch 17111/17108, but there is no relationship between these 4 complaints and this adverse event: (b)(4) : article code (b)(4) : 5 single-dose containers of caphosol b do not carry a lot number and expiry date. (b)(4): customer received caphosol liquid instead of caphosol dispersible. (b)(4): pack received damaged by customer. (b)(4): damaged product received by client. Conclusions: recurrent complaint: no. Complaint was justified: yes. Recall initiated: no. Complaint rejected: no. Final classification of complaint: critical. As of 12 sep 2018, analysis on retention sample are currently in progress by the manufacturer. Further information is expected. Company comment: swollen tongue and dysphagia were assessed as serious (hospitalization). Swollen tongue and dysphagia are unlisted, as per the caphosol (calcium phosphate) instruction for use. Information in the report is very limited, precluding proper causality assessment. Therefore causal relationship between swollen tongue, dysphagia and caphosol (calcium phosphate) were assessed as possibly related. Further information will be requested. This single case report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012120603-2018-00001 |
| MDR Report Key | 8127977 |
| Report Source | OTHER |
| Date Received | 2018-12-04 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-08-02 |
| Date Added to Maude | 2018-12-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIPIKA MISTRY |
| Manufacturer Street | BREAKSPEAR PARK,BREAKSPEAR WAY HEMEL HEMPSTEAD |
| Manufacturer City | HP2 4TZ |
| Manufacturer Country | UK |
| Manufacturer Postal | HP2 4TZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPHOSOL |
| Generic Name | CAPHOSOL ARTIFICIAL SALIVA TABLETS |
| Product Code | LFD |
| Date Received | 2018-12-04 |
| Lot Number | 17108, 7111 |
| Device Expiration Date | 2020-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EUSA PHARMA (US) LLC |
| Manufacturer Address | NJ 08691, US HAMILTON NJ 08691 US 08691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-04 |