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.
[22042898]
Customer reported a female patient with a leg cast was itchy and had open wounds under the cast. The female patient was reportedly treated with an oral antibiotic and wet to dry gauze was applied. No further information was obtained.
Patient Sequence No: 1, Text Type: D, B5
[22198737]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2013-00008 |
| MDR Report Key | 2981117 |
| 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 | 2013-02-28 |
| 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 JOHNSON, SPECIALIST |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6514303467 |
| 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 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 |