MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-15 for CURFAK300RB manufactured by Medline Industries Inc..
[117256283]
It was reported that a (b)(6) child experienced a scrape on his shin which his mother reportedly covered with over the counter antibiotic cream and a bandage. The child's mother stated that 30 minutes after the application of the bandage her son started to experience blisters in the area of the bandage adhesive and was gasping for breath like he was experiencing an anaphylactic reaction. The child's mother stated that she went to the pharmacy, got an epi-pen and injected her son with the epi-pen which resolved the symptoms of gasping for breath. The child's mother stated that she covered the blisters on the shin with a gauze pad and tape without further incident. The child has a known allergy to latex but no other known allergies were reported. The child's mother called the child's pediatrician the morning after the incident occurred to report the child's symptoms and the use of an epi-pen and the pediatrician instructed the mother to monitor the child and no follow up was necessary at this time. The actual sample is not available to be returned for evaluation due to the actual sample involved in the incident being thrown away. No additional information is available. Due to the reported incident, need for intervention and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[117256284]
It was reported that the end user developed an allergic reaction after wearing the bandage and was treated with an epi-pen injection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00076 |
| MDR Report Key | 7786073 |
| Report Source | CONSUMER |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-07-26 |
| Date Added to Maude | 2018-08-15 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DR |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FIRST AID KIT WITHOUT DRUG |
| Product Code | OHO |
| Date Received | 2018-08-15 |
| Catalog Number | CURFAK300RB |
| Lot Number | 75716090003 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-15 |