MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-04 for ORS-100 FLUID WARMER DRAPE manufactured by Microtek Dominicana, S.a..
[104549469]
No sample was available for evaluation. Multiple lots were provided by the end user: d171869, d172279, d171859, d172029, d172399. The dhrs were reviewed and it was noticed that: d172279: this lot had (b)(4) pcs that were manufactured on 08/15/2017. No defects were reported during quality inspections. D171859: this lot had (b)(4) pcs that were manufactured from 07/06/2017 to 07/07/2017. No defects were reported during quality inspections. D172029: this lot had (b)(4) pcs that were manufactured on 07/21/2017. No defects were reported during quality inspections. D172399: this lot had (b)(4) pcs that were manufactured from 08/28/2017 to 08/29/2017. No defects were reported during quality inspections. D171869: this lot had (b)(4) pcs that were manufactured from 07/07/2017 to 07/10/2017. No defects were reported during quality inspections. Based on the device history record review, this does not appear to be the result of a personnel, process or material issue. The non conformity could not be confirmed since no sample was returned for review. Because no sample was returned the non conformity could not be confirmed and the root cause for this investigation is undetermined. No additional actions will be taken at this time. If additional information or sample becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[104549470]
Customer complained that drape had pinhole prick in it that was found after the case ended. Drape came from one of lot numbers above, but they threw away the drape itself. Need an analysis of lot numbers to make sure there's aren't compromised. The or noted "the patient had a post operative infection that was due to a feeding tube and unlikely due to the product deficiency. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-00009 |
| MDR Report Key | 7397224 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-13 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-04-04 |
| 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 JENNIFER MRKVICKA |
| Manufacturer Street | 1 ECOLAB PLACE |
| Manufacturer City | ST. PAUL MN 55102 |
| Manufacturer Country | US |
| Manufacturer Postal | 55102 |
| Manufacturer Phone | 6512502237 |
| Manufacturer G1 | MICROTEK DOMINICANA |
| Manufacturer Street | ZONA FRANCA NO. 2 |
| Manufacturer City | LA ROMANA, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORS-100 FLUID WARMER DRAPE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2018-04-04 |
| Returned To Mfg | 2018-04-13 |
| Model Number | ORS-100 |
| Lot Number | SEE H10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA NO. 2 LA ROMANA, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-04 |