MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-17 for UNKNOWN TED manufactured by Covidien.
[75361108]
Submit date: 05/17/2017. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[75361109]
The customer states that a patient from the ambulatory ward slid/fell while walking with ted stockings and no shoes. She fell on her bottom and knocked her head on the bed. She had no bruises but complained of shoulder pain. She was hospitalized and imagery showed a fracture and a vertebral compression. She then had a kyphoplasty surgery due to the fracture and vertebral compression. The patient had no previous history and came the same day resection of an axillary nodule. The customer further reports that the surgery went well. The surgery following the event added 5 days of hospitalization.
Patient Sequence No: 1, Text Type: D, B5
[96876865]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[109675997]
No sample or picture was provided by the customer for evaluation. Additionally, device history record could not be reviewed since there was no lot number provided. Potential root causes could be related to improper use of product by the customer and material used to manufacture the product. This defect has not been confirmed, since there is no enough evidence provided by the customer such as sample, lot number, item code or picture. As per the manufacturing process, all controls related to the acceptance of the product are in place and personnel is appropriately trained in order to prevent getting nonconforming product from the manufacturing process. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2017-05110 |
| MDR Report Key | 6572692 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-17 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-02-20 |
| Date Mfgr Received | 2017-03-08 |
| Date Added to Maude | 2017-05-17 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 0101 |
| Manufacturer Postal Code | 0101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | DWL |
| Date Received | 2017-05-17 |
| Model Number | UNKNOWN TED |
| Catalog Number | UNKNOWN TED |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 0101 0101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-17 |