MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-03-08 for PROCARE 79-97958 manufactured by Djo, Llc.
[101892995]
Complaint received that alleges patient feels that she was not given proper instruction on the care at the clinic where it was applied, she was told not to remove it due to the severity of a humeral brace, she did not realize that she needed to remove the brace and clean the arm and replace the sleeve, because she didn't realize this the sleeve got very moldy, and caused severe skin issues, this was noticed on (b)(6) 2018 when she had taken her son to the emergency they had instructed her in the wait area to remove the moldy sleeve immediately, and they disposed of it, meanwhile shortly afterwards in the emergency room when the dr wanted to examine the area they cut off the other sleeve and disposed of it as well. Questionnaire not received from customer or clinician. Device not received manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2018-00003 |
| MDR Report Key | 7324268 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-03-08 |
| Date of Report | 2018-03-08 |
| Date of Event | 2018-02-23 |
| Date Added to Maude | 2018-03-08 |
| 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 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, 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 | OVER-THE-SHLDR HUMERAL CUF,XL |
| Product Code | NOC |
| Date Received | 2018-03-08 |
| Model Number | 79-97958 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2018-03-08 |