MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for TUBIGRIP A-433-4 45792 manufactured by Molnlycke Healthcare, Us Llc.
[65685203]
Patient Sequence No: 1, Text Type: N, H10
[65685204]
A patient who is allergic to latex was being seen by physical therapy (pt). The therapist sized, fitted, and issued a product containing latex (tubigrip) to be worn around knee. The therapist was under the impression the product was latex-free at the time of issue. Therapist contact patient immediately after being informed by clinical manager and instructed patient to stop using and discard it immediately. Patient expressed understanding and reported no allergic reaction to product. The therapist suggested internal fixes to avoid this from happening: keep product in original packaging while stored. Review products containing latex with staff. Physically separate latex-containing products from rest of equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6275521 |
| MDR Report Key | 6275521 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-23 |
| Date of Event | 2017-01-21 |
| Report Date | 2017-01-22 |
| Date Reported to FDA | 2017-01-22 |
| Date Reported to Mfgr | 2017-01-22 |
| Date Added to Maude | 2017-01-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUBIGRIP |
| Generic Name | DRESSING, COMPRESSION |
| Product Code | MHW |
| Date Received | 2017-01-25 |
| Model Number | A-433-4 |
| Catalog Number | 45792 |
| ID Number | MULTIPURPOSE TUBULAR BANDAGE, |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTHCARE, US LLC |
| Manufacturer Address | 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-25 |