MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for A PLUS INTERNATIONAL N/A LS-1818-PS manufactured by A Plus International.
[102224739]
Resource optimization and innovation, llc is a registered convenience kit manufacturer. The component, a bulk non-sterile finished medical device (lap sponge) is used in the kit as received from the component manufacturer (a-plus international, (b)(4)). The kit is assembled, sterilized and supplied sterile as single-use kits for patient use. The component was a lap sponge 18x18 pre-washed look banded 5, catalog no. Ls-1818-fs, lot no. 405921, 510(k) no. 881395. The blue cord broke off of the lap sponge and the rubber band aournd lap sponges disintegrated. This was identified while using the sponges on a patient.
Patient Sequence No: 1, Text Type: N, H10
[102224740]
Blue cord broke off of lap sponge and rubber band around the lap sponges was disintegrating. This was identified while using the sponges on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004513970-2018-00001 |
| MDR Report Key | 7328613 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-08 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2018-03-09 |
| 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 | MRS. DEBRA SEILLING-FERGUSON |
| Manufacturer Street | 2909 N. NEERGARD |
| Manufacturer City | SPRINGFIELD MO 65803 |
| Manufacturer Country | US |
| Manufacturer Postal | 65803 |
| Manufacturer Phone | 4168209037 |
| Manufacturer G1 | RESOURCE OPTIMIZATION AND INNOVATION, LLC |
| Manufacturer Street | 2909 N. NEERGRAD |
| Manufacturer City | SPRINGFIELD MO 65803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 65803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | A PLUS INTERNATIONAL |
| Generic Name | LAP SPONGE |
| Product Code | EFQ |
| Date Received | 2018-03-09 |
| Model Number | N/A |
| Catalog Number | LS-1818-PS |
| Lot Number | 405921 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A PLUS INTERNATIONAL |
| Manufacturer Address | CHINO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-09 |