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 2020-03-26 for ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 400 ML, 2-14 ML/HR CB004 101347203 manufactured by Avanos Medical - Irvine.
[188346604]
(b)(4). The actual complaint product was not returned for evaluation. A review of the device history record is in-progress. All information reasonably known as of 25-mar-2020 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by avanos medical, inc. Represents all of the known information at this time. Avanos medical, inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical, inc. Complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188346605]
Avanos medical received a single report that referenced two different incidences, which were associated with separate units, involving two different events. This is the first of two reports. Refer to 2026095-2020-00043 for the second event. Fill volume: 400 ml. Flow rate: 4 ml/hr. Procedure: endoscopic carpal tunnel with ulnar nerve repair. Cathplace: unknown. It was reported the patient used the elastomeric pump for a elbow/ulnar procedures. The pump infused at 4ml/hr. The patient came into the clinic with no pain but was swollen with neuropraxias. The patient will be going to the occupational therapy (ot) and therapy for the edema. Additional information received 18-mar-2020 stated the product was used in accordance with instructions. The user or facility conditions did not contribute to the incident. The drug was not a contributor or potential contributor to the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2026095-2020-00042 |
| MDR Report Key | 9882549 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-26 |
| 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 | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT S. DE R.L. DE C.V. |
| Manufacturer Street | AVE NORUEGA EDIFICIO D-1B FRACCIONAMIENTO RUBIO |
| Manufacturer City | TIJUANA B.C. 22116 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 400 ML, 2-14 ML/HR |
| Generic Name | ELASTOMERIC - SAF |
| Product Code | MEB |
| Date Received | 2020-03-26 |
| Model Number | CB004 |
| Catalog Number | 101347203 |
| Lot Number | 2002966 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL - IRVINE |
| Manufacturer Address | 43 DISCOVERY SUITE 100 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |