MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-01-13 for 3M SCOTCHCAST PLUS CASTING TAPE 82002G manufactured by 3m Healthcare.
[17473187]
The patient stated that he had a radial bone osteotomy and a plaster splint was applied. He had percocet post-op and was fine although he has a history of itching from percocet. The following month at 5pm, a scotchcast cast was applied. Around 8-9pm, he started itching between his thumb and forefinger where the cast touched his skin, by 10pm, the area was swelling, by midnight, the area was discolored. He cut the cast away and his palm was purple and oozing pus, and at 3am, he had red spots on his face and legs. The next day at 6:30am, he had hives all over his body and went to the doctor. The scotchcast was removed and replaced with a plaster cast. By 8pm, he had a 102. 5 fever and the bottoms of his feet were too painful to walk. He went to the er at 9pm, he was admitted, and the reaction got worse for 4 days. He was diagnosed with urticaria and treated with steroids and benadryl. He received 3 injections per day of heparin in the abdomen, and when the needle was removed, there was a hive that grew, he had a red outline/hive around the iv needle that grew, and tape left an outline that grew into hives, until the hives grew together. He was given dilaudid every 2 hours. Three days later, it was still bad and two days later, it had almost cleared up. He uses polyurethane a lot around the house and has used fiberglass insulation.
Patient Sequence No: 1, Text Type: D, B5
[17548171]
There is no evaluation done on device itself. The adverse event was a type i immediate hypersensitivity reaction. The evaluation was based on the patient's history, the event happened to the patient, the picture of the reaction site and the treatment. Sensitization.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2009-00001 |
| MDR Report Key | 1289480 |
| Report Source | 04 |
| Date Received | 2009-01-13 |
| Date of Report | 2009-01-09 |
| Date of Event | 2008-11-06 |
| Date Mfgr Received | 2008-12-02 |
| Date Added to Maude | 2009-08-25 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JIZHONG JIN |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517336655 |
| Manufacturer G1 | 3M POLAND SP. ZO.O |
| Manufacturer Street | UI.KWIDZYNSKA 6 |
| Manufacturer City | WROCLAW 51-416 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 51-416 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SCOTCHCAST PLUS CASTING TAPE |
| Generic Name | CASTING TAPE |
| Product Code | ITG |
| Date Received | 2009-01-13 |
| Model Number | NA |
| Catalog Number | 82002G |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTHCARE |
| Manufacturer Address | 3M CO., BLDG 275-5W-06 ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2009-01-13 |