MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-02 for PLUS ED75000992 manufactured by Smith & Nephew, Inc.
[16837928]
A customer contacted baxter's technical service center regarding the home choice (hc) problem of a patient that stated two of his supply bags fell off the table, this problem occurred during dwell. The technical service representative (tsr) assisted the home patient (hp) as the hp stated both of his supply bags fell off the table and disconnected from the tubing in day dwell 1 of 1. The tsr then assisted the hp to cycle power and then explained to start over with all new supplies. The tsr explained to the hp he needed to drain out his dwell before he filled back up again. The hp stated ok. No patient injury or medical intervention was reported. Product surveillance contacted the nurse on (b)(6) 2010. The nurse stated the following: the patient had reported the incident and no adverse events were reported. The patient was doing fine with therapy.
Patient Sequence No: 1, Text Type: D, B5
[18113239]
It was reported that revision surgery was performed due to a fracture of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613369-2010-00042 |
| MDR Report Key | 1824267 |
| Report Source | 07 |
| Date Received | 2010-09-02 |
| Date of Report | 2010-09-02 |
| Date of Event | 2010-07-08 |
| Date Mfgr Received | 2010-08-06 |
| Date Added to Maude | 2010-11-09 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. MELANIE TRAVIS |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996233 |
| Manufacturer G1 | AARAU SWITZERLAND MANUFACTURING SITE |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLUS |
| Generic Name | FEMORAL HEAD |
| Product Code | LPF |
| Date Received | 2010-09-02 |
| Catalog Number | ED75000992 |
| Lot Number | 003056 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC |
| Manufacturer Address | SCHACHENALLEE 29 AARAU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-09-02 |