MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-11 for EYETEC 40-410-USA manufactured by Network Medical Prodcucts (usa) Inc.
[51936817]
Product inspection: product was returned to nmp-usa by distributor ((b)(4) full box, (b)(4) partial w/6 pouches). (b)(4) pouches were opened and spears examined dry for frayed edges. The number of spears per pouch with obvious edge fraying was quantified. Photos were taken of the worst example in each pouch. Spears were then submerged in water and rubbed vigorously back and forth several times over a hard surface, to exaggerate actual use. No spears fell apart. Spears from (b)(4) additional lots spanning manufacturing dates from april, 2014 to december, 2015 were examined in the same fashion. No significant differences were noted in quantity or degree of fraying. The subject lot was not unusually frayed as compared with other cellulose lots. Batch records of the suspect lot were checked: final inspection form for the suspect lot, dated november 21, 2015, showed no anomalies. Inspector/packer trained on the inspection procedure on april 23, 2015. Sterilisation records checked by production manager on october 30, 2015. Dose exposure confirmed, sterilisation lot number traced to nmp product ref and lot #s. Sterilisation coc signed october 30, 2015. Shipment to steriliser packed by production manager on september 25, 2015, (b)(4) traced to (b)(4). (b)(4) spears, production dates prior to and including september 25, 2015, were packed by trained operators: operator 1 (trained jun. 14,2014), operator 2 (august 21,2014), operator 3 (july 22, 2015), operator 4 (september 10, 2015). (b)(4) spears, production dates prior to and including september 25, 2015, cut by trained operators: operator 1 (june 30, 2014), operator 2 (september 17, 2015). Sprig shipments (b)(4) received and inspected by production supervisor (trained september 29, 2015) and found to be acceptable and unremarkable. Raw material lot 110194, shipments of which were received at nmp-usa july 24, august 12 and september 22, 2015. All lots inspected by supervisor production supervisor (trained june 30, 2015) and found to be acceptable. A level of particulate is common to all spears industry wide. No deficiencies in product quality could be identified. Conclusion - device was inappropriately used (surgical site insufficiently irrigated). No further action proposed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[51936818]
Distributor reported end user feedback from customer monticello surgery via email that a patient had to have additional surgery to remove a retained piece of cellulose foam in the patient's eye. No information was given about the type of procedure conducted with the cellulose spear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011093388-2016-00001 |
| MDR Report Key | 5867907 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-11 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-03-09 |
| Date Mfgr Received | 2016-03-09 |
| Date Added to Maude | 2016-08-11 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ALISON MARCH |
| Manufacturer Street | 183 PROV-NEW LONDON TPKE SUITE W9 |
| Manufacturer City | NORTH STONINGTON CT 063591721 |
| Manufacturer Country | US |
| Manufacturer Postal | 063591721 |
| Manufacturer Phone | 8604952055 |
| Manufacturer G1 | NETWORK MEDICAL PRODUCTS (USA) INC. |
| Manufacturer Street | 183 PROV-NEW LONDON TPKE SUITE 9 |
| Manufacturer City | NORTH STONINGTON CT 063591721 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 063591721 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EYETEC |
| Generic Name | CELLULOSE SPEAR |
| Product Code | HOZ |
| Date Received | 2016-08-11 |
| Model Number | 40-410-USA |
| Catalog Number | 40-410-USA |
| Lot Number | 15EST0128 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NETWORK MEDICAL PRODCUCTS (USA) INC |
| Manufacturer Address | 183 PROV-NEW LONDON TPKE, SUITE W9 NORTH STONINGTON CT 063591721 US 063591721 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-11 |