MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-20 for SCOTCHCAST PLUS CASTING TAPE, 82003G manufactured by 3m Health Care.
[1724473]
The 3m received information that a medical assistant had an anaphylactic reaction after removing a patient's scotchcast plus cast. It was reported that the medical assistant developed a rash on her forearms and that her face became "itchy". After rubbing her face, the patient observed a rash on her face and swelling around her eyes. The medical assistant also reported having to keep clearing her throat; on the way to the emergency room she was "panting like a dog". Upon examination, she was diagnosed with an anaphylactic reaction and treated with solu-medrol (methylprednisolone sodium succinate), epinephrine, a medrol (oral methylprednisolone) dose pack, hydroxyzine, hydralazine and oral benadryl. Additional information indicated that the medical assistant had removed many casts in the past without a reaction. She had a lot of dust on her arms and the medical facility does not have a vacuum on the cast cutter. A 3m technical service specialist was consulted. The specialist did not know what may have caused the reaction but suggested a food reaction. No other adverse patient effects were reported. If additional information is received, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[8813252]
A product lot number was not provided. Device expiration date cannot be determined. Product was not returned. No evaluation could be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2010-00119 |
| MDR Report Key | 1950546 |
| Report Source | 05 |
| Date Received | 2010-10-20 |
| Date of Report | 2010-09-20 |
| Date of Event | 2010-09-16 |
| Date Mfgr Received | 2010-09-20 |
| Date Added to Maude | 2011-01-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANDREA GRABANSKI |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517331047 |
| Manufacturer G1 | 3M JAPAN HEALTH CARE |
| Manufacturer Street | 500 OSANAGI |
| Manufacturer City | HIGASHINE-SHI |
| Manufacturer Country | JA |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOTCHCAST PLUS CASTING TAPE, 82003G |
| Generic Name | CASTING TAPE |
| Product Code | ITG |
| Date Received | 2010-10-20 |
| Model Number | NA |
| Catalog Number | 82003G |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| 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 | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2010-10-20 |