MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-09 for PREVANTICS DEVICE SWAB manufactured by Professional Disposables International Inc..
[141432560]
On (b)(6) 2019 pdi was informed that a patient experienced an anaphylaxis reaction on (b)(6) 2019 shortly after her perma cath access hub was prepped for dialysis using the prevantics antiseptic device swab. According to the facility administrator, the patient's initial symptom was swelling, followed by the patient coding which required resuscitation for approx. 8 minutes. Patient was intubated while in the icu. Providers did experience difficulty placing the intubation tube due to throat swelling. Patient spent a "couple" of days in the icu and was extubated prior to being moved to a step-down unit. Patient has been discharged from the hospital and is currently stable. Date of discharge is unknown. No changes in patient's care/condition since the anaphylaxis reaction, continues with dialysis 3x a week. Patient was noted as having skin allergy to chg on her medical chart prior to her dialysis treatment and use of this product. Unknown if she has any other allergies. Facility administrator added that patients with known chg allergies are prepped with alcohol prep pads only, and therefore the perma cath access hub should not be cleaned with chg products prior to dialysis treatment. Facility administrator advised that the prevantics product was used to clean the patient's hub during previous dialysis treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411192-2019-00001 |
| MDR Report Key | 8497487 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-09 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-13 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2019-04-09 |
| 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. WENDY GOULD |
| Manufacturer Street | TWO NICE PAK PARK |
| Manufacturer City | ORANGEBURG NY 10962 |
| Manufacturer Country | US |
| Manufacturer Postal | 10962 |
| Manufacturer Phone | 8457925396 |
| Manufacturer G1 | PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. |
| Manufacturer Street | TWO NICE PAK PARK |
| Manufacturer City | ORANGEBURG NY 10962 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREVANTICS DEVICE SWAB |
| Generic Name | CHG 3.15% AND IPA 70% SWAB |
| Product Code | LKB |
| Date Received | 2019-04-09 |
| Lot Number | 11801707 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROFESSIONAL DISPOSABLES INTERNATIONAL INC. |
| Manufacturer Address | TWO NICE PAK PARK ORANGEBURG NY 10962 US 10962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-09 |