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 2017-11-17 for C8405, XXL ALEXIS O WND PRO/RET 5/BX 101356501 manufactured by Applied Medical Resources.
[93296691]
No product is being returned for evaluation, but a lot # is provided. A device history report is to be reviewed by engineering. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[93296692]
Procedure performed: whipple procedure event description: possible blistering occurring after a large size alexis was used in a longer case. On (b)(6) the (b)(6) was informed by the hospital that in around 5 whipple cases with the alexis o xl and xxl the surgical team noticed the presence of "flittene" (small skin area with water blister, as in the case of burns) in the area of pressure of the white outer ring, directly after the alexis removal. Additional information received from applied medical team member, 25th october: this was one of the cases. The alexis was placed by a resident. Skin preparation was done with an iodine solution, and wiped before the alexis/drape was placed. Because of the burns in previous cases the surgical team put a wet drape under the white alexis ring. Upon removal, burns were visible on the entire left side of the patients abdomen. Also, some skin stuck to the wet drape and came lose and there was some necrosis of the skin. No pictures were taken. Whipple cases are usually long, this case lasted 5:25 hours. The patient was young for this type of case (<30) and had a (b)(6). The hospital did not log if the alexis xl or xxl was used, so this information is not available. We do have the lot numbers for both sizes: xl lot 1299212 and xxl lot 1296027. It was clarified that there were actually 4 cases, and not 5 as originally thought. Additional information received from the hospital, 2nd november: the lesions were like flittene/blister in the upper right abdominal quadrant, approximately below the metal retractor. There were about 8-10 small lesions around 0,5 cm or less each. Nothing special was seen when the alexis was removed. In all cases, the or was the or 1. In every patient, the junior resident was placed on the right side and his pressure was on the metal retractor. In all cases, the lesions were flittene/blisters not like the picture that seems to be a burn. Type of intervention: the wound was treated with gaze with wheat germ oil/triticum vulgare. Patient status: did a patient injury or illness occur associated with the complaint event? Yes. The patient was ok.
Patient Sequence No: 1, Text Type: D, B5
[96773934]
The event unit was not returned to applied medical for evaluation. As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed. In the absence of the subject device, it is difficult to determine the root cause of the event. Applied medical has reviewed the details surrounding the event and related product. At this time, applied medical is unable to determine the root cause of the reported event or confirm that a product malfunction occurred. Although the root cause of the reported event could not be confirmed, applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Patient Sequence No: 1, Text Type: N, H10
[96773935]
Additional information was received via email, on from senior regulatory affairs specialist, on january 3, 2018. "this hospital most probably received those lots directly from the sales rep because they are doing a specific study with the (b)(6)it means that model number regarding these cers is definitely c8404 (as per mdv report) and not as informed. " additional information received from applied medical tm on january 8, 2018: "based on the lot trace, however, lot number indeed doesn't match with these incidents. This lot was delivered to the hospital only in october (after the incidents), and there`s no trace that was delivered even to the rep. Customer most likely gave us a wrong lot number, probably what they still had on their shelves. Considered the above explanation, lot trace attached and communication back and forth between us, the rep and clinical team in ame, we concluded that for these cers the lot number is unknown. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-02115 |
| MDR Report Key | 7043527 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-17 |
| Date of Report | 2018-01-09 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2017-10-18 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2017-11-17 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| 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 | 2017-11-17 |
| Model Number | C8405 |
| Catalog Number | 101356501 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-17 |