MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-07 for BULK PACK TRANSDUCER PROTECTOR 04-9500-2 manufactured by Erika De Reynosa, S.a. De C.v..
[92481726]
A supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[92481727]
A clinic manager from a hemodialysis (hd) patient's facility reported during hd treatment the transducer protector came loose from the dialysis lines and experienced blood loss during the event. Additional follow-up revealed the transducer protector came loose one hour after treatment was initiated. The estimated blood loss was 20mls. No patient injury or medical intervention was required. The patient was monitored and her vital signs remained stable. No defect or damage was observed to the transducer protector or its packaging. The patient was able to successfully complete treatment on the same machine. The sample was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2017-00947 |
| MDR Report Key | 7008581 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-07 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-11-06 |
| Date Mfgr Received | 2017-11-23 |
| Device Manufacturer Date | 2016-01-15 |
| Date Added to Maude | 2017-11-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BULK PACK TRANSDUCER PROTECTOR |
| Generic Name | PROTECTOR, TRANSDUCER, DIALYSIS |
| Product Code | FIB |
| Date Received | 2017-11-07 |
| Catalog Number | 04-9500-2 |
| Lot Number | 16AR01005 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-07 |