MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-03-06 for 3M SCOTCHCAST ONE STEP SPLINT 86335 manufactured by 3m Health Care.
[5464492]
A male had a 3m splint placed on his left forearm and elbow on (b)(6) 2015 following an accident the day before. The splint and his arm were wrapped in an elastic bandage. Within the next few days the male alleged blistering and weeping of the skin around the edge of the splint. The splint was removed around (b)(6) 2015. The male alleged 2-3cm blisters over his arm; the blisters were allegedly worse on the inner side of the arm and on the elbow joint. The male was given an unidentified steroid injection, fluocinonide cream, furosemide (a diuretic) and an unidentified antibiotic. His surgery was postponed for one week. Additional information provided by the male that occurred subsequent to the reportable event noted above. The male had surgery on his left elbow on approximately (b)(6) 2015 that involved a joint implant (radial head). The male alleged his wound did not heal adequately. Bactrim was prescribed which he stated had no effect. The implant was removed and a picc line placed on (b)(6) 2015 for receiving iv vancomycin.
Patient Sequence No: 1, Text Type: D, B5
[12986150]
This is a very rare event based on product complaint history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2015-00011 |
| MDR Report Key | 4595222 |
| Report Source | 00 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-02-20 |
| Date of Event | 2015-01-23 |
| Date Mfgr Received | 2015-02-20 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-03-13 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SCOTCHCAST ONE STEP SPLINT |
| Generic Name | PROSTHETIC AND ORTHOTIC ACCESSORY |
| Product Code | IPM |
| Date Received | 2015-03-06 |
| Model Number | NA |
| Catalog Number | 86335 |
| Lot Number | 2017-07 UG |
| ID Number | NA |
| Device Expiration Date | 2017-07-01 |
| 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 HEALTH CARE |
| Manufacturer Address | ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-06 |