MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-02 for 3M? SCOTCHCAST? COMFORTABLE SPLINT N/A 72335 manufactured by 3m Healh Care.
[112851600]
Pt identifier, weight, ethnicity and race: this patient information was not provided. Date of event was not provided. Product lot # and serial # information was not provided. Without the lot number, it is not possible to provide the expiration date, udi, or manufacture date. Device was not returned by customer for evaluation. This is a very rare event based on product complaint history. The initial reporter stated the splint was applied on backwards by the user, in error, due to product unfamiliarity. The instructions for use states :3m? Scotchcast? Conformable splint is intended for use in the construction of common orthopedic splints. Specific splinting application suitability should be the responsibility of a qualified, on-site medical professional. Attempts are being made to obtain more information. End of report.
Patient Sequence No: 1, Text Type: N, H10
[112851601]
A hospital employee reported that the a 3m? Scotchcast? Comfortable splint (model 72335) was used on a (b)(6), male infant. Duration of wear or date incident occurred was not specified. The employee reported the splint was applied on backwards by the user, in error, due to product unfamiliarity. The employee reported the infant required hospitalization, reconstructive surgery with skin graft, and treated with antibiotics for cellulitis. Length of hospitalization stay not specified. Patient's current status not specified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00063 |
| MDR Report Key | 7654310 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-02 |
| Date of Report | 2018-07-02 |
| Date Mfgr Received | 2018-06-05 |
| Date Added to Maude | 2018-07-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M POLAND MANUFACTURING |
| Manufacturer Street | WROCLAW UI. KWIDZYNSKA 6 |
| Manufacturer City | WROCLAW, POLAND 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? COMFORTABLE SPLINT |
| Generic Name | PROSTHETIC AND ORTHOTIC ACCESSORY |
| Product Code | IQI |
| Date Received | 2018-07-02 |
| Model Number | N/A |
| Catalog Number | 72335 |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALH CARE |
| Manufacturer Address | 2510 CONWAY AVE. ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-02 |