MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-21 for 3M SYNTHETIC CAST PADDING CMWO6 manufactured by 3m Health Care.
[3168792]
It was reported that a female patient with a leg cast developed a rash that spread all over her body. The female patient was reportedly treated with an oral antibiotic and referred to a wound specialist. She went to her dermatologist who prescribed a cream. No further information was obtained.
Patient Sequence No: 1, Text Type: D, B5
[10568878]
No lot number was provided and without this information it is not possible to determine the required information in these sections as to the manufactured date and/or expiration date. The product was not returned to 3m for evaluation. Method- actual device not evaluated and no testing methods performed. Results- no results available sine no evaluation performed. Conclusion- device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2013-00007 |
| MDR Report Key | 2978450 |
| Report Source | 06 |
| Date Received | 2013-02-21 |
| Date of Report | 2013-02-01 |
| Date of Event | 2013-01-28 |
| Date Mfgr Received | 2013-02-01 |
| Date Added to Maude | 2013-02-27 |
| 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, SPECIALIST |
| 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 |
| 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 SYNTHETIC CAST PADDING |
| Generic Name | (ITG) PROSTHETIC AND ORTHOTIC ACCESSORY |
| Product Code | ITG |
| Date Received | 2013-02-21 |
| Model Number | NA |
| Catalog Number | CMWO6 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2013-02-21 |