MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-12-30 for ACTIVECARE +SFT SYSTEM WARNING: A502B000101 manufactured by Zimmer Surgical, Inc..
[173252075]
This event is recorded by zimmer biomet under (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet. Once the product is returned and the investigation is complete, a follow up/final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[173252076]
It was reported that the patient stated that she only wore the device for two days. The patient's skin was fragile, and the device was ripping open her skin. The patient was told by pt to stop using the device. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2019-01202 |
| MDR Report Key | 9530276 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-12-30 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-22 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2018-05-02 |
| Date Added to Maude | 2019-12-30 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVECARE +SFT SYSTEM WARNING: |
| Generic Name | SLEEVE, LIMB, COMPRESSIBLE |
| Product Code | JOW |
| Date Received | 2019-12-30 |
| Catalog Number | A502B000101 |
| Lot Number | 63985102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-30 |