MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-11 for COMFORT RECLINE SPACER 8E4230 manufactured by Handicare Usa.
[97878376]
(b)(4). Initial/final report was sent on dec. 12, 2016 to health (b)(4) for a comfort recline spacer h/s- xl sling investigated in (b)(4) on 10/31/16 via rga (b)(4). (b)(4) evaluated the sling. The pommel strap was not attached and was not included with the sling. The sling has broken threads where the pommel pouch connects to the main body of the sling. The pommel strap had been previously sewn on. The pommel strap is an optional feature added to the sling to keep the legs separated. Detachment does no present risk in use. The pommel pouch could become detached if: girth of leg is too large. The individual is not centered or the weight shifts during lifting. The individual is too heavy. The pommel strap has been attached to a hook on the carry bar, rather than being looped over the hip straps as shown above. Root cause: unable to establish definitive root cause of detachment. Corrective action: customer service contacted the customer to see if there were questions on the correct method of use for the comfort recline spacer sling and how to properly attach the pommel straps and pouch. They also reminded the customer there is an instructional video on the website that can be viewed. The comfort recline sling is sold with the pommel pouch added as an optional feature. Handicare us has implemented ecr 1219 to add sliders to the pommel so it can be adjusted for leg girth and shifting of weight.
Patient Sequence No: 1, Text Type: N, H10
[97878377]
During a lift, using a comfort recline spacer sling, the pommel strap on used to keep the legs separated, detached from the sling. The shoulder and leg staps remained attached to the lift. The patient was lowered to the bed and was uninjured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802293-2018-00003 |
| MDR Report Key | 7184432 |
| Date Received | 2018-01-11 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-12-08 |
| Date Mfgr Received | 2017-12-12 |
| Date Added to Maude | 2018-01-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | REKHA JANARTHANAN |
| Manufacturer Street | 10888 METRO COURT |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal | 63043 |
| Manufacturer Phone | 3142198642 |
| Manufacturer G1 | HANDICARE USA |
| Manufacturer Street | 10888 METRO COURT |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMFORT RECLINE SPACER |
| Generic Name | COMFORT RECLINE SPACER |
| Product Code | ILE |
| Date Received | 2018-01-11 |
| Model Number | 8E4230 |
| Operator | NURSING ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE USA |
| Manufacturer Address | 10888 METRO COURT MARYLAND HEIGHTS MO 63043 US 63043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-11 |