MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-05-04 for BAND-AID HYDROCOLLOID 0037131782 manufactured by Coloplast As.
[44392281]
This foreign report is being submitted on 04-may-2016 for a device product that is considered same/similar to a us marketed device (bab adv healing blister finger toe 8s). This is an initial submission for the second product in this case. The manufacturer report number for this submission is 9610694-2016-00102. The manufacturer report number for the first product in this case is 9610694-2016-00101. This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
[44392282]
This spontaneous report was received on 06-apr-2016 from a (b)(6) male consumer reporting on self from (b)(6). The medical history and concomitant medications were not reported. On (b)(6) 2016, the consumer started using band-aid kpp jumbo 3 2013, cutaneously, for two to three days, to heal a two-centimeters sized shallow wound with infection (used for a dirty wound) between the wrist and the elbow (lot number and expiration date unspecified). After two to three days of usage in 2016, he developed discomfort and redness around the wound, the wound smelled bad, and the device was replaced with a new one. On (b)(6) 2016, he visited hospital and consulted an orthopedist, plastic surgeon, and dermatologist who told him the skin of the affected area had become necrotic and skin grafting would be required. The action taken with the device was unknown. The event did not resolve. This report was assessed as serious (medically significant). The company causality was assessed as related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610694-2016-00102 |
| MDR Report Key | 5631056 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-05-04 |
| Date of Report | 2016-04-06 |
| Date Mfgr Received | 2016-04-06 |
| Date Added to Maude | 2016-05-04 |
| 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 | NI JULIE THOMAS |
| Manufacturer Street | JOHNSON & JOHNSON CONSUMER INC 199 GRANDVIEW ROAD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9082557895 |
| Manufacturer G1 | COLOPLAST AS |
| Manufacturer Street | HOLTEDAM 1 HUMLEBAEK REGION |
| Manufacturer City | HOVEDSADEN DK3050 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK3050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAND-AID HYDROCOLLOID |
| Generic Name | CLOSURE, WOUND, ADHESIVE |
| Product Code | MGO |
| Date Received | 2016-05-04 |
| Model Number | 0037131782 |
| Catalog Number | NI |
| Lot Number | UNKNOWN |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST AS |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK REGION HOVEDSADEN DK3050 DA DK3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-04 |