MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-07-16 for 3M SCOTCHCAST WET OR DRY CAST PADDING WDP3 manufactured by 3m Healthcare.
[880268]
According to the initial reporter, the patient was treated with scotchcast wet or dry cast padding for a distal radium/ulnar fracture, closed reduction. Two weeks and 6 days later, after the patient was in water during vacation, he was presented to the clinic with significant breakdown, grade 2-3 ulceration on the arm distal to the elbow at the top of the cast, in the webspace between the thumb and index finger, and the ulnar side of the palm. The physician assistant applied a removable splint, and the patient was sent to wound care and was treated with a xeroform dressing. The physician assistant said the padding was wet.
Patient Sequence No: 1, Text Type: D, B5
[8020484]
This is class 1 product. In summary, based on the information reported, 3m was not provided enough information to draw a conclusion if other factors contributed to the events. Sample was received on 7/7/2008 and the product analysis is currently in process. The physicians instructions for use contains the following statements: indications: scotchcast wet or dry cast padding is intended for use in constructing casts for either wet or dry immobilization.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2008-00012 |
| MDR Report Key | 1078468 |
| Report Source | 05,06 |
| Date Received | 2008-07-16 |
| Date of Report | 2008-07-15 |
| Date of Event | 2008-06-20 |
| Date Mfgr Received | 2008-06-20 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2008-07-28 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICA MORRIS, ASSOCIATE |
| Manufacturer Street | BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517336791 |
| Manufacturer G1 | ROGERS CORPORATION |
| Manufacturer Street | ONE TECHNOLOGY DRIVE |
| Manufacturer City | ROGERS CT 06263021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06263 0217 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SCOTCHCAST WET OR DRY CAST PADDING |
| Generic Name | CAST PADDING |
| Product Code | ITG |
| Date Received | 2008-07-16 |
| Model Number | NA |
| Catalog Number | WDP3 |
| Lot Number | 2012-05 02 |
| ID Number | NA |
| Device Expiration Date | 2012-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1047133 |
| Manufacturer | 3M HEALTHCARE |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN 55144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-16 |