MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for ACUFEX ACCESS ADV POS KIT 72205104 manufactured by Smith & Nephew, Inc..
[141015190]
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Patient Sequence No: 1, Text Type: N, H10
[141015191]
It was reported that during the surgery the arm was wrapped and being held by the physicians assistant, it did not hold the arm. The physicians assistant had just connected patients wrapped arm to the access tower, and when the weights were applied to pull traction, the patient brace was pulled off the patient's forearm. A backup device was used to complete the surgery. No significant delay or patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2019-00245 |
| MDR Report Key | 8479022 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-05-27 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-05-23 |
| Device Manufacturer Date | 2018-10-26 |
| Date Added to Maude | 2019-04-03 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACUFEX ACCESS ADV POS KIT |
| Generic Name | COMPONENT, TRACTION, NON-INVASIVE |
| Product Code | KQZ |
| Date Received | 2019-04-03 |
| Catalog Number | 72205104 |
| Lot Number | 50766949 |
| 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 | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |