MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2014-04-30 for 3M SCOTCAST WET OR DRY CAST PADDING EDP2 manufactured by 3m Health Care.
[4475820]
Hold - ab 05/09/2014 it was reported that a (b)(6) male suffered skin maceration under the casting materials used at a user facility. The patient's father stated that he allowed his son to swim in a pool and bathe, but never allowed him to swim or play in any lakes, rivers or oceans. The father reported that there was significant excoriation of the skin with a rash involving the entire area underneath the cast with some peeling of the skin that was prominent. Patient's parents were advised to proceed with local wound care and follow-up treatment. Parents scheduled followed-up treatment with family doctor (3 visits) for wound care. The doctor gave the patient a shot as a precautionary measure for infection and advised the parents to apply topical antibiotic cream and dressing to their son's arm twice a day until the skin recovered. The patients father stated that this went on for approximately 3 months, but patient is doing well now. The initial report was sent to the company on (b)(4) 2014 by the user facility as the bill for services went into collections. No sample and no lot number were provided. The facility contact that reported the complaint to company representative did not respond to attempts to obtain additional information regarding the alleged incident. A certified letter has been sent.
Patient Sequence No: 1, Text Type: D, B5
[11781448]
A voluntary 2013 recall was initiated after and investigation of customer feedback was conducted and internal testing was performed, it was found that the cast padding material did not consistently repel water. Lack of repellency may result in prolonged cast drying times after exposure to wet conditions. Fda assigned recall number was: z-2242-2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2014-00024 |
| MDR Report Key | 3800242 |
| Report Source | 00,05,06,07 |
| Date Received | 2014-04-30 |
| Date of Report | 2014-03-20 |
| Date of Event | 2013-08-23 |
| Date Mfgr Received | 2014-03-20 |
| Date Added to Maude | 2014-05-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA JOHNSEN |
| Manufacturer Street | 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SCOTCAST WET OR DRY CAST PADDING |
| Generic Name | BANDAGE, CAST |
| Product Code | ITG |
| Date Received | 2014-04-30 |
| Model Number | NA |
| Catalog Number | EDP2 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-30 |