MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-03 for PROCARE 79-95335 manufactured by Djo, Llc.
[32663294]
Not returned for review.
Patient Sequence No: 1, Text Type: N, H10
[32663295]
Per 21cfr part 803, an mdr reportable event. Complaint received via medwatch (mw5057727) that alleges "male admitted on (b)(6) 2015 secondary 2 degree to delirium. On (b)(6) 2015 staff noted concern on l medial malleolus. Woc aprn assessed and found stage ii hapu likely due to cam boot. Pt admitted with cam boot. On (b)(6) 2015, hapu progressed to stage iii due to infection of wound. Cam boot discontinued. Event abated after use stopped or dose reduced; yes. Diagnosis or reason for use: diabetic foot w/poa wound". Questionnaire was not received from clinician and/or patient. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[54574131]
Product was returned for review. Item is not very used, side bars are not aligned one to another, do not match, one is bent a side, also is missing a locking key pin on right side dorsi flexion adjustment unit. Side bars, these are little stiff to move back and forward, not aligned, velcro's are good. Possible adjustment problems.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2015-00031 |
| MDR Report Key | 5265397 |
| Date Received | 2015-12-03 |
| Date of Report | 2015-12-03 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2016-08-10 |
| Date Added to Maude | 2015-12-03 |
| 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 | 3 |
| Manufacturer Contact | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, MEXICO 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCARE |
| Generic Name | MAXTRAX ROM WALKER, |
| Product Code | IPG |
| Date Received | 2015-12-03 |
| Model Number | 79-95335 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-03 |