MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-10-16 for 3M SCOTCHCAST WET AND DRY CAST PADDING WDP2 manufactured by 3m Health Care.
[16536195]
It was reported that one patient had an infection and it took 45 minutes to remove the cast. The patient was sent to their pediatrician. No further information on the patient was provided.
Patient Sequence No: 1, Text Type: D, B5
[16604857]
No lot number was provided. Without the lot number, we are not able to determine the expiration date nor the device manufacture date. Product exempt from premarket notification. The product was not returned to 3m for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2012-00044 |
| MDR Report Key | 2818434 |
| Report Source | 06 |
| Date Received | 2012-10-16 |
| Date of Report | 2012-09-11 |
| Date of Event | 2012-09-11 |
| Date Mfgr Received | 2012-09-11 |
| Date Added to Maude | 2012-11-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA JOHNSEN |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | ROGERS CORPORATION |
| Manufacturer Street | ONE TECHNOLOGY DRIVE P.O. BOX 217 |
| 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 AND DRY CAST PADDING |
| Generic Name | (ITG) PROSTHETIC AND ORTHOTIC ACCESS |
| Product Code | ITG |
| Date Received | 2012-10-16 |
| Model Number | NA |
| Catalog Number | WDP2 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-16 |