MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for UNK manufactured by Applied Medical Resources.
[129180620]
No product is being returned for evaluation and no lot # 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
[129180621]
Procedure performed: emergency resection laparotomy. During a surgery, yesterday, they found inside the abdomen a whole alexis after a surgery happened in 2017. The person who reported this event admitted that must have been user error but they will in any case proceed with their internal protocol for these type of events. Additional information received via email from applied medical team member, (b)(6): they have not kept the device due to it being adhered greatly to the bowel, they do have photographs which i have asked to be sent to me the original procedure was in mary 2017 and was a hartmann? S patient returned to or last week due to abdominal pain and was taken into emergency theatres for an emergency resection laparotomy. There was imaging down which showed a small bowel mass (which was the mainly the alexis encased in bowel) the alexis was a small, but they do not have the lot number the alexis was fully intact, with both rings and plastic sheath the case was done in emergency theatres with a scrub nurse who was not a typical scrub for colorectal cases and may not have had any exposure to the alexis the surgeon for both cases (2017 and last week) was the same surgeon (they were reluctant to give me the name) however, jane advised that the surgeon in the cases of 2017 where the alexis was left, left the assistant to close the patient. This assistant had not been working at dorset county for long at this time. Again, i do not have their name. At that time they never considered to account for alexis in their scrub/plastic count patient current status, jane is aware she went to itu but from her understanding is stable, i do not know if the patient has been made aware of the issue additional information received via email from applied medical team member, (b)(6) : the patient was discharged to home on (b)(6) and is recovering well once the investigations are complete they have asked us to come retrain everyone the patient has been made aware of what has occurred patient status: patient is stable. Type of intervention: emergency theatres for an emergency resection laparotomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00429 |
| MDR Report Key | 8074398 |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-11-15 |
| 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 |
| Manufacturer G1 | APPLIED MEDICAL RESOURCES |
| Manufacturer Street | 22872 AVENIDA EMPRESSA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNK |
| Generic Name | UNK |
| Product Code | KGW |
| Date Received | 2018-11-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-11-15 |