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 2017-11-16 for C8405, XXL ALEXIS O WND PRO/RET 5/BX 101356501 manufactured by Applied Medical.
[93296350]
No product is being returned for evaluation and no lot number has been provided to manufacturer. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[93296351]
Procedure performed - laparotomie = laparotomy. Event description - bij het plaatsen van de alexis xxl werd geconstateerd dat de alexis xxl niet geheel de wondranden bedekt. De functie van wondbescherming gaat dan verloren. De buikwand met vet drkt zich buiten de alexis xxl. Translation ra-qa: when placing the alexis xxl it was discovered that the alexis xxl does not completely cover the wound edges. The functionality of the wound protection then becomes lost/ineffective. The abdominal wall with fat then pushes itself outside the alexis xxl. Additional information was received via email on november 3, 2017 from sr clinical development mgr: "information from applied medical team member october 25, 2017: last week i attended an open gyn case where the alexis o xxl was used. They performed an hysterectomy and as a sampling removed ten glands from all different regions. The midline incision ran from the pubic symphysis around the umbilicus and 2- cm upwards, according to the surgeon an approximately 25 cm incision. The patient was (b)(6) female with a (b)(6). Her larger posture was quite centered around her belly area. Complication: the alexis xxl was unable to cover the wound margins completely. The wound margin popped out on two sides. We advised to loosen the ring by flipping it back two times, this improved the situation but the wound margins were still exposed at the two sides (just a bit less). However, flipping the alexis o back, also resulted in losing a bit of the retraction. In the end, the surgeon wasn't completely satisfied with the exposure and switched to munster retractor. She preferred the [competitor] retractor over the alexis o, however, she appreciated that alexis o was so quick to set up. Information from applied medical team member october 26, 2017: the exposed wound margins (on two sides) with the alexis xxl looked similar to the drawing below" patient status - no patient injury or illness occurred associated with the complaint event type of intervention - n/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-02114 |
| MDR Report Key | 7038231 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-16 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-10-18 |
| Date Facility Aware | 2017-10-18 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-11-16 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8405, XXL ALEXIS O WND PRO/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2017-11-16 |
| Model Number | C8405 |
| Catalog Number | 101356501 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-16 |