MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for BREWER ACCESS EXAM TABLE 5000-04 manufactured by 2182356.
[139163390]
According to the reporting person, a "rather large" patient placed his left hand on and somewhat under the upholstered top. When he sat on the table, his left hand middle finger was cut by something sharp, and his finger/nail fell on floor. The plastic surgical repair was the next morning using a skin graft of pig's skin. When i asked her to clarify "rather large", she stated (b)(6) lb. She stated that "apparently the bumpers fall off easily... After the incident, when we looked at the 37 tables in the clinic, we found 18 tables that were missing one or both of the bumpers. " she had their service company come in to replace the missing bumpers. The table was most recently inspected in january by their service company. Picture sent by the reporting person showed no bumper or screw on one side. The reporting person stated that there was not a specific sharp edge on the table. (refer to mw5081405).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182536-2018-00001 |
| MDR Report Key | 8430505 |
| Date Received | 2019-03-18 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2002-07-17 |
| Date Added to Maude | 2019-03-18 |
| 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 | EMILY VANDE HEI |
| Manufacturer Street | N88 W13901 MAIN STREET SUITE 100 |
| Manufacturer City | MENOMONEE FALLS WI 53051 |
| Manufacturer Country | US |
| Manufacturer Postal | 53051 |
| Manufacturer Phone | 2622937164 |
| Manufacturer G1 | THE BREWER COMPANY LLC |
| Manufacturer Street | N88 W13901 MAIN STREET SUITE 100 |
| Manufacturer City | MENOMONEE FALLS WI 53051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53051 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREWER ACCESS EXAM TABLE |
| Generic Name | CHAIR, EXAMINATION AND TREATMENT |
| Product Code | FRK |
| Date Received | 2019-03-18 |
| Model Number | 5000-04 |
| Catalog Number | 5000-04 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 16 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 2182356 |
| Manufacturer Address | N88 W13901 MAIN STREET SUITE 100 MENOMONEE FALLS WI 53051 US 53051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-03-18 |