MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-09 for CVS ENHANCED WOUND WASH, 4 OZ BOTTLE CVSWC0412 manufactured by Derma Sciences, Inc..
[104802990]
The device was not returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[104803011]
It was reported by a patient that on (b)(6) 2018, the right arm of the patient was wounded and went to the nearest emergency room. Cvs zinc wound wash was used to clean the wound. However, upon using the same product at home, the patient experienced discomfort after a week of usage. Infection was noted and the patient went to another physician. Oral and topical antibiotics were prescribed. On (b)(6) 2018, the arm is still inflamed and is painful. No further patient complications were reported. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2018-00013 |
| MDR Report Key | 7409693 |
| Date Received | 2018-04-09 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-04-02 |
| Date Added to Maude | 2018-04-09 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | DERMA SCIENCES, INC. |
| Manufacturer Street | 104 SHORTING ROAD |
| Manufacturer City | TORONTO, ONTARIO M1S 3S4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | M1S 3S4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CVS ENHANCED WOUND WASH, 4 OZ BOTTLE |
| Generic Name | PRIVATE LABEL - CVS |
| Product Code | KMF |
| Date Received | 2018-04-09 |
| Catalog Number | CVSWC0412 |
| Lot Number | F17423 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DERMA SCIENCES, INC. |
| Manufacturer Address | 104 SHORTING ROAD 104 SHORTING ROAD TORONTO, ONTARIO M1S 3S4 CA M1S 3S4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-09 |